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Job Description ABOUT IMMUNEERING Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic Inhibition platform. Our lead asset, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK in active Phase 2 and Phase 3 (MAPKeeper 301) clinical trials in pancreatic cancer and RAS-mutant non-small cell lung cancer, as well as additional solid tumor programs. We are committed to delivering transformative treatments to patients with limited options through rigorous science and a collaborative, mission-driven culture. POSITION SUMMARY This is a foundational hire. As Immuneering’s first US-based field medical employee, this role will establish the company’s scientific presence with key opinion leaders and academic oncology centers nationwide. This role is best suited for a senior MSL who is willing to engage with KOLs enthusiastically and build a rapport with the scientific community, with the strategic vision and potential to grow into a leadership position within a lean, mission-driven organization. The selected MSL may have the opportunity to assist with the company’s international MSL buildout across Western Europe, Central-Eastern Europe, and the Australia/APAC region, and could quickly step into the role of Field Medical Director. US Field Medical Affairs • Develop and manage peer-to-peer scientific relationships with oncology KOLs, academic investigators, and institutional stakeholders at priority centers including MSKCC, City of Hope, OHSU, and the SCRI/USON/OneOncology networks and others., • As a major priority, this individual will support investigator identification and engagement for MAPKeeper 301 Phase 3 enrollment; facilitate site activation and scientific readiness at high-enrolling centers., • Deliver accurate, balanced, and compliant scientific exchange on Immuneering’s Deep Cyclic Inhibition mechanism, MAPKeeper in metastatic pancreatic cancer, atebimetinib + cemiplimab in RAS-mutant NSCLC and other possible studies related to the MAPK pathway., • Respond to unsolicited medical information requests from healthcare professionals in accordance with FDA guidelines on scientific exchange., • Generate and communicate field insights — including HCP perspectives, competitive intelligence, and clinical practice patterns — to Medical Affairs, Clinical, and Commercial stakeholders., • Provide flexible US territory coverage (East, Central/South, West) based on enrollment priorities and KOL geography., • Represent Immuneering at national and regional oncology congresses (possibly including ASCO, AACR, ESMO and others). Global MSL Network Leadership • Partner with Medical Affairs leadership to develop scientific messaging frameworks, training curricula, and field activity standards for the global consultant network., • May quickly transform into a leadership position as the Field Medical Director, which would entail managing the buildout of Immuneering’s OUS consultant MSL network across the UK/Western Europe, Central-Eastern Europe (Poland, Czech Republic, Hungary, Romania), and Australia/APAC., • Contribute to MSL infrastructure, SOPs, and reporting frameworks as Immuneering scales toward commercialization or partnership. Education • Advanced degree in a health science discipline (MD, PharmD, PhD, or MSN/NP/PA with oncology specialization), • 3–5+ years of MSL experience in oncology; prior experience at a biotech or clinical-stage company strongly preferred Technical / Soft Skills Required • Established KOL relationships in pancreatic cancer, thoracic oncology, or a closely adjacent tumor type, • Deep understanding of clinical trial design, oncology drug development, and FDA-compliant scientific exchange, • Ability to translate complex mechanistic science (RAS/MAPK pathway biology, adaptive resistance, combination strategies) for diverse oncology audiences, • Willingness and ability to travel 50–60% domestically; occasional international travel for global team alignment and congresses, • US-based; eligible to work in the United States without sponsorship Preferred • Background in RAS/MEK pathway biology, GI oncology, or thoracic oncology, • Experience supporting Phase 2 or Phase 3 clinical trial enrollment as an MSL, • Prior experience in a lead MSL, field medical director, or senior leadership field medical role, • Familiarity with medical affairs operations in an international or multi-regional context, • Experience working with or coordinating medical affairs consultants or CRO-based MSL models EQUAL OPPORTUNITY EMPLOYER Immuneering Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Job Description About Synchron Synchron’s vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Senior Director, Regulatory Affairs Location: San Diego, California (Onsite) Department: Regulatory Reports to: VP, Regulatory and Quality About the Role We are seeking a Senior Director of Regulatory Affairs will serve as the senior regulatory leader for Synchron’s San Diego operations, providing strategic and operational oversight across software, firmware, and hardware regulatory activities. This role will own regulatory strategy for new BCI platform development, with oversight of ongoing product updates, and manufacturing-related submissions, working closely with cross-functional teams in engineering, quality, and clinical to ensure regulatory readiness at every stage of the product lifecycle. Key Responsibilities • Regulatory Strategy and Submissions, • Lead regulatory strategy and submission planning for software, firmware, and hardware for new product development programs and product updates, • Author and manage IDE, PMA, and PMA supplement submissions to the FDA; support additional international filings as needed, • Develop and execute software and firmware regulatory strategy for complex BCI devices, including AI/ML considerations, software and firmware change management, and lifecycle documentation in compliance with applicable guidance, • Provide regulatory support for manufacturing-related activities, including process changes and design transfers, • Cross-Functional Leadership, • Partner with engineering, software, quality, clinical, and operations teams to integrate regulatory requirements from early development through commercialization, • Provide regulatory guidance on new product concepts, design inputs, and technology transfers, • Support project planning and roadmaps with well-defined regulatory milestones and risk assessments, • Regulatory Intelligence and Compliance, • Monitor evolving FDA regulations, guidance documents, and international standards relevant to Class III implantable devices and complex software- and firmware-driven medical technologies, • Ensure ongoing compliance with IDE and approved submission commitments, including reporting obligations and correspondence management, • Represent Synchron in FDA meetings, pre-submission interactions, and agency correspondence, • Minimal travel expected (<10% of the time). Potential planned travel for FDA meetings, cross-site collaboration, and conferences., • Perform other duties and responsibilities as assigned Required Qualifications • Bachelor’s degree in engineering, life sciences, or a related field; advanced degree preferred., • 12+ years of regulatory affairs experience in the medical device industry, with progressive responsibility including demonstrated experience with complex, high-risk (Class III) active implantable neurological or cardiac devices., • Strong software and firmware regulatory expertise for complex medical devices, including experience with AI/ML-enabled features, software and firmware change management, and applicable FDA guidance, • Track record of leading FDA submissions (IDE, PMA, supplements) and managing agency interactions independently, • Familiarity with manufacturing-related regulatory considerations, including process changes and design transfers, in a device development or scale-up context, • Experience supporting new product development from concept through submission, including design control and risk management integration, • Deep knowledge of 21 CFR Parts 820, 812, 814, and applicable international standards, • Exceptional written and verbal communication skills; ability to translate regulatory complexity for engineering and executive audiences, • Effective time management and interpersonal skills, • Builds productive internal and external working relationships Preferred Qualifications • RAC certification (RAPS), • Experience with brain-computer interfaces, neural stimulation, or implantable neurotechnology, • Familiarity with OUS regulatory pathways (CE Mark, TGA, or similar), • Experience scaling a regulatory function at a growth-stage medical device company Key Competencies • Strong attention to detail and commitment to accuracy, • Excellent problem‑solving, • Effective written and verbal communication, • Ability to partner cross‑functionally and influence stakeholders, • Strong organizational and project management skills, with comfort operating in a lean, startup‑style environment Compensation The base salary range for this role is $210,000 – $240,000 depending on experience, skills, and qualifications. In addition to base salary, this role may be eligible for discretionary bonuses and/or equity grants, subject to board approval and company policy. Visa Sponsorship We are unable to offer visa sponsorship for this position currently. Benefits (for W-2, full-time, exempt employees in the US only) *Intern positions not eligible • Subsidized medical and dental insurance coverage for you and your dependent(s), • Life insurance, short-term disability, long-term disability, • 401k, • Discretionary unlimited PTO, • Flexible Spending Account for you and your dependent(s), with eligible plan elections, • Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply now and build the future with us.

Job Description Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families. Umoja Biopharma – Your Body. Your Hope. Your Cure. POSITION SUMMARY The Vice President, Clinical Development is a strategic and operational leader responsible for advancing the company's clinical-stage pipeline through all phases of clinical development. This role provides leadership and oversight for the Clinical Development organization, including Medical Directors and Clinical Scientists. The VP will lead the development and execution of integrated clinical development strategies, ensuring high-quality, compliant, and efficient clinical programs that support regulatory approvals and commercialization objectives. As a key member of the Clinical Development Leadership Team, this role collaborates closely with Regulatory Affairs, Translational Medicine, Research, CMC, Quality, Commercial, and Executive Leadership to drive clinical and corporate objectives. This role will ideally be based out of our Seattle, WA location and work onsite at least 2 days/week. We are open to remote on the West Coast for the right candidate with the expectation to be in Seattle 5 business days per month. CORE ACCOUNTABILITIES: Specific responsibilities include: • Lead the overall clinical development strategy for the company's portfolio, ensuring alignment with corporate and regulatory objectives., • Partner with the CMO and Executive Leadership team to define development pathways, clinical endpoints, and regulatory strategies., • Build and develop a high-performing, scalable clinical organization of Medical Directors and Clinical Scientists. Establish clear goals, metrics and development plans for team members and leaders in alignment with Umoja's values and principles., • In collaboration with the CMO, communicate the clinical vision and emerging data to the Board, investors and potential partners, helping articulate the value, differentiation and development potential of Umoja's pipeline., • Shape the long-term clinical development strategy translating emerging clinical, translational and competitive insights into indication selection, sequencing and investment recommendations., • Define the clinical path for establishing in vivo CAR-T as a new therapeutic modality, including evidence generation that differentiates Umoja from conventional autologous, allogeneic, and other in vivo cell-therapy approaches., • Evaluate emerging clinical data, competitive intelligence, and scientific developments to inform development plans., • Serve as a key contributor to portfolio prioritization, resource planning, and investment decisions., • Drive accountability, operational excellence, and cross-functional collaboration., • Ensure appropriate staffing, vendor management, and resource allocation across programs., • Ensure clinical studies are conducted on time, within budget, and in compliance with regulatory requirements., • Lead clinical governance processes, risk management, and portfolio prioritization., • Oversee safety monitoring, data quality, and clinical study reporting., • Ensure inspection readiness and compliance with GCP, ICH, FDA, and global regulations., • Provide scientific and clinical expertise to business development, investor relations, and partnership discussions as needed., • Partner with Regulatory Affairs in preparing global regulatory submissions and agency interactions., • Participate in meetings with health authorities, including FDA, EMA, and other international agencies., • Support preparation of briefing documents, submission packages, and responses to regulatory inquiries., • Build and lead a network of external scientific and clinical advisors, establishing Umoja as a preferred partner for investigators, thought leaders, vendors, partners, and scientific organizations in hematologic oncology, cell therapy and autoimmune field. The successful candidate will have: • Significant experience within biotechnology, pharmaceutical, or related life sciences organizations., • Prior experience leading clinical development functions and multidisciplinary teams is highly preferred., • Demonstrated success leading clinical programs through multiple stages of development, including late-stage and registration-enabling studies., • Experience supporting regulatory interactions and submissions., • Cell and gene therapy or advanced modality experience preferred., • Hematology/oncology, immunology, rheumatology, or advanced therapeutic experience strongly preferred., • Strategic thinker with strong scientific and business acumen., • Proven ability to lead and scale high-performing teams., • Excellent communication, influence, and stakeholder management skills., • Demonstrated ability to operate effectively in a dynamic, fast-paced biotech environment. Physical Requirements: • The ideal candidate will be able to work onsite based out of our Seattle, WA office at least 2 days/week. There may be the ability to work remotely on the west coast and travel to Seattle, WA at least 5 days/month., • Ability to travel domestically and, if applicable, internationally (typically up to 30–50%, depending on role), including air travel and extended periods away from home., • Ability to attend and actively participate in external meetings, some of which may require travel., • Ability to sit for prolonged periods of time. Salary Range: $320,000 - $400,000 Benefits Offerings Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Regulatory Affairs Manager Location: Onsite - San Diego, CA Position Summary: The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances. Key Responsibilities: • Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies., • Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards., • Provide regulatory support to product development teams by offering guidance on applicable regulations and documentation requirements., • Stay current on changes in regulatory requirements and assist in assessing the impact on company processes and products., • Perform regulatory assessments for product changes and propose appropriate regulatory pathways., • Maintain documentation and records of all regulatory submissions and correspondence., • Support the preparation for regulatory agency meetings, audits, and inspections., • Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory deliverables are met in a timely manner. Requirements Education: • Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required., • Master’s degree preferred. Professional Experience: • 5–7 years of regulatory affairs experience within the medical device or IVD industry., • Working knowledge of 510(k) submissions and regulatory documentation processes., • Experience interacting with FDA and other regulatory agencies preferred. Skills & Competencies: • Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, and medical device regulatory requirements., • Strong organizational and project management skills with the ability to manage multiple projects and priorities., • Excellent communication, problem-solving, and attention to detail., • Ability to work collaboratively in cross-functional teams and manage document workflows. Benefits • Highly competitive compensation package., • Comprehensive medical, dental, and vision insurance., • 401(k) plan with generous company contributions., • Flexible paid time off (PTO) policy., • Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Job Description The Associate Director, Clinical Operations will be responsible for managing operational aspects of assigned clinical trials, with a focus on early-phase oncology studies. This includes oversight of contract research organizations (CROs), vendors, and clinical sites across both U.S. and international regions. The role requires a deep understanding of clinical trial processes, regulatory compliance (GCP, FDA, ICH), and the ability to lead cross-functional teams to ensure high-quality, timely, and cost-effective trial execution. The ideal candidate will bring an in-depth understanding of managing early phase oncology trials at a sponsor biotech. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Lead the planning, initiation, execution, and close-out of complex Phase I oncology trials. Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations., • Manage and oversee external partners including CROs, central labs, biometrics, safety vendors, eTMF providers, and others. Ensure deliverables are met on time, within budget, and to quality standards., • Manage, mentor, and support direct reports, fostering professional development and team performance., • Participate in site selection, feasibility assessments, and initiation visits. Build strong relationships with investigators and site staff to support efficient enrollment and high-quality data collection., • Oversee the development and review of essential study documents such as protocols, informed consent forms, case report forms (CRFs), monitoring plans, and study manuals., • Review monitoring reports and ensure timely resolution of issues. Provide guidance to CRO monitors and ensure appropriate sponsor oversight is documented., • Conduct ongoing data reviews and support data cleaning activities. Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF)., • Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders., • Work closely with internal stakeholders including Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and CMC to ensure alignment and smooth execution of clinical programs., • Provide guidance and mentorship to junior team members and cross-functional colleagues. Share best practices and contribute to continuous process improvement., • Prepare and deliver study updates, metrics, and presentations to senior leadership. Represent Clinical Operations in internal and external meetings., • Contribute to the development and implementation of SOPs, work instructions, and operational tools to enhance team efficiency and compliance., • Willingness to travel up to 15% for site visits, vendor meetings, and conferences., • Other activities as assigned. In addition to a competitive base salary ranging from $175,000 to $200,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available. Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location. Job Type: Full-time Benefits:· Annual bonus program· Incentive stock option plan· 401k plan with flat non-elective employer contribution · Comprehensive medical insurance with 90-100% employer-paid premiums · Dental and vision insurance· HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity) · Unlimited PTO · Generous holiday schedule; includes summer and winter company shutdown · Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· On site (San Diego, CA) EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name "Erasca" has an important embedded meaning: it is a contraction of our audacious hope to "erase cancer" that drives our mission and everything that we do on behalf of patients with cancer. Position Summary: Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA development and maintenance for support of new and ongoing clinical trials, as well as planning for future MAA/NDA/BLA(s). This role requires an independent, self-directed, and highly motivated regulatory professional. Position Responsibilities: • Deliver CMC regulatory support through QC review of submission components, including CMC documents, labeling, application forms, supporting GMP documentation, cover letters and verification of submission links, ensuring completeness, consistency, and compliance with regulatory requirements., • Prepare and/or review CMC regulatory documents and submissions to support product development (e.g. ND/CTAs, DSUR, health authority briefing document, iPSP/PIP, NDA/MAA) Provide oversight of regulatory submission content and planning, to assure technical accuracy, compliance, and completeness., • Assess proposed CMC changes (e.g., manufacturing processes, analytical methods, specifications, manufacturing sites, container closure systems, stability programs, and suppliers) and support development of appropriate global regulatory filing strategies., • Collaborate cross-functionally on the eTMF processes and compliance alignment., • Represent regulatory on study and program teams throughout study conduct and product development., • Support or lead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required., • Review relevant clinical and CMC documents (protocol, informed consent form, investigator's brochure, and site quality documentation, and required regulatory forms) for regulatory compliance and consistency across submission components., • Maintain current knowledge of US and international CMC regulation requirements that apply to company products and processes., • Support or lead development of internal Erasca SOPs and processes, as needed., • May support other global submission activities as appropriate, independently or in collaboration with the Regulatory Affairs project lead., • Perform all duties in keeping with the Company's core values, policies, and all applicable regulations. Position Requirements: • Undergraduate degree required; advanced degree preferred., • 5+ years of experience in pharmaceutical or biotech regulatory affairs or related areas, including regulatory affairs for oncology products., • Ability to translate regulatory requirements into practical workable plans., • Diverse experience with regulatory activities including creation of systems and processes to support efficient and high quality submission of documents to regulatory bodies., • Strong organizational skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail., • Ability to build strong relationships with co-workers of various backgrounds and expertise., • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment., • Effective interpersonal and communication skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems., • Strong learning orientation, curiosity, and commitment to science and patients. The anticipated salary range for this position is $175,000 to $205,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off, Holiday, and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erasca contribution, and the opportunity to participate in an Employee Stock Purchase Program. Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

Job Description Lead the global chemistry, manufacturing, and controls (CMC) strategy, process optimization, and contract manufacturing network for therapeutic oligonucleotides to ensure the seamless, compliant supply of drug substance and drug product across clinical pipeline phases. Accountabilities: • Design and execute phase-appropriate global CMC development strategies for therapeutic oligonucleotides from late-stage discovery through advanced clinical testing to achieve corporate pipeline milestones., • Direct external Contract Development and Manufacturing Organizations (CDMOs) and analytical testing laboratories, overseeing technology transfers, process scale-ups, and cGMP campaigns., • Optimize solid-phase oligonucleotide synthesis, cleavage, deprotection, purification, and lyophilization processes to maximize production yields and ensure operational efficiency., • Oversee the development, qualification, and validation of analytical methods for release testing, stability monitoring, and impurity characterization to maintain high product quality., • Partner with the Quality Assurance team to review and approve master batch records, executed runs, and stability protocols to ensure unconditional compliance with cGMP and phase-appropriate regulatory guidelines., • Author, review, and finalize CMC technical sections (Module 3) for global regulatory filings (including INDs, IMPDs, and NDAs) to facilitate rapid health authority approvals., • Formulate technical data packages and precise written responses to CMC-related inquiries from global regulatory agencies (including the US FDA and EMA)., • Serve as the primary CMC representative on cross-functional program teams, collaborating closely with Discovery Biology, Translational Research, Regulatory Affairs, and Clinical Operations to ensure clinical trial material readiness., • Forecast long-term chemical material needs and manage chemical raw inventory pools (including amidites and solid supports) to de-risk global clinical supply chains. Requirements Required Knowledge and Experience • Demonstrated technical depth leading outsourced cGMP manufacturing operations and managing technology transfers with international CDMOs., • Proven competence in therapeutic oligonucleotide chemistry (including ASOs, siRNA, and sgRNA), phosphoramidite workflows, conjugation strategies, and advanced purification techniques., • Advanced working knowledge of analytical chemistry specific to oligonucleotides, with deep expertise in sequence confirmation, impurity profiling, and stability control strategies., • Thorough understanding of global regulatory guidelines (ICH, FDA, and EMA) regarding the development, characterization, and manufacturing specifications of synthetic oligonucleotides., • Exposure to or direct experience tracking targeted delivery systems for oligonucleotides, such as GalNAc conjugates or lipid nanoparticles (LNPs)., • Advanced educational background (PhD level preferred) in Organic Chemistry, Biochemistry, Chemical Engineering, or a highly related life sciences discipline. HAYA Therapeutics is an Equal Opportunity Employer committed to fostering a diverse, inclusive, and equitable workplace where all individuals feel valued and empowered. We provide equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, or gender expression), national origin, ancestry, age, marital or familial status, veteran status, disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws. We prohibit discrimination and harassment of any kind and are committed to ensuring fair and equitable treatment in all aspects of recruitment, hiring, promotion, compensation, benefits, training, and career development. At HAYA, we believe that diversity of thought, experience, and background drives innovation and strengthens our mission to transform patient care through cutting-edge RNA-based therapeutics.

Job DescriptionDescription: The Associate Director, Medical Writing & Scientific Communications will be a key member of the Medical Affairs organization, responsible for developing and executing strategic scientific communication initiatives that support clinical development, medical affairs priorities, and commercial launch readiness. In this role, the Associate Director will lead the creation of high-quality, scientifically rigorous medical communications across publications, congress activities, scientific platforms, advisory boards, and healthcare provider engagement initiatives. The ideal candidate brings deep expertise in medical writing and scientific communications within the biotechnology or pharmaceutical industry, demonstrated ability to translate complex clinical data into meaningful scientific narratives, and experience collaborating cross-functionally with Medical Affairs, Clinical Development, Regulatory Affairs, and external scientific experts. This is a unique opportunity to build a foundational scientific communications capability within a growing organization and make a meaningful impact on advancing innovative therapies for patients living with chronic disease. Essential Duties and Responsibilities The main responsibilities of this role include: • Develop and execute strategic medical writing and scientific communication plans aligned with Medical Affairs objectives and company priorities, • Lead the development of scientific communication deliverables, including peer-reviewed manuscripts, abstracts, posters, oral presentations, scientific slide decks, advisory board materials, and medical education resources, • Partner with Medical Affairs leadership and cross-functional stakeholders to establish scientific narratives, evidence communication strategies, and disease-state education platforms, • Support publication planning activities, including development and execution of publication plans in collaboration with internal stakeholders, external authors, and medical writing agencies, • Ensure scientific communications are accurate, balanced, compliant, and aligned with applicable guidelines, including Good Publication Practice (GPP) and International Committee of Medical Journal Editors (ICMJE) recommendations, • Translate complex clinical trial data, scientific literature, and healthcare trends into clear and compelling communications for healthcare professionals, investigators, and internal stakeholders, • Support medical affairs activities including:, • Medical Science Liaison training and scientific preparation, • Investigator meetings, • Advisory boards, • Congress planning and execution, • Medical information resources, • Internal scientific communications, • Collaborate closely with Clinical Development, Regulatory Affairs, Biostatistics, Commercial, Market Access, and other internal partners to ensure consistency of scientific messaging, • Manage external medical writing agencies, consultants, and scientific communication vendors, • Establish scalable medical writing processes, templates, and best practices to support a growing Medical Affairs organization, • Lead and/or contribute to cross-functional project teams supporting scientific communications strategy and execution, • Maintain and continuously enhance scientific expertise through ongoing review of clinical data, scientific literature, healthcare trends, and competitive intelligence, • Complete all required administrative duties, training, and compliance-related activities in a timely manner, • Other duties as assigned Requirements: Education and Experience • Pharm.D., Ph.D., M.D., D.O., or other advanced scientific degree preferred, • Minimum of 5 years of progressive experience in medical writing, scientific communications, medical affairs, or related roles within a biotechnology or pharmaceutical organization, • Demonstrated experience developing peer-reviewed publications, scientific congress materials, and clinical communication deliverables, • Current experience supporting Medical Affairs, Scientific Affairs, Clinical Development, or related functions within the biotechnology or pharmaceutical industry, • Proven scientific expertise in obesity, cardiometabolic disease, metabolic disorders, or related therapeutic areas preferred, • Strong understanding of clinical trial design, interpretation of clinical data, and evidence-based scientific communication Knowledge and Skills • Exceptional scientific writing, editing, and communication skills with strong attention to detail, • Ability to synthesize complex scientific information and communicate actionable insights to diverse audiences, • Experience developing strategic scientific narratives and communication platforms, • Strong knowledge of publication standards, including GPP and ICMJE guidelines, • Ability to manage multiple projects, priorities, and timelines in a fast-paced environment, • Strong analytical, organizational, and problem-solving skills, • Demonstrated ability to collaborate effectively with internal and external partners, • Self-motivated individual with an entrepreneurial mindset and ability to operate independently, • Strong interpersonal skills and professional demeanor, • Excellent verbal and written communication skills, • Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel), collaboration platforms, and virtual communication tools VIKING THERAPEUTICS Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Salary Description $170,000.00 - $190,000.00 annual salary

Job Description About Artiva: We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies. For more information, visit www.artivabio.com. Job Summary: • The Supply Chain Buyer/Planner is responsible for leading end-to-end inventory and materials management in support of a GMP-regulated (and non-GMP) biologics/pharmaceutical manufacturing environment. This role will own the full Raw Material lifecycle—from raw material planning and ordering through inventory control—ensuring uninterrupted, compliant, and cost-effective material flow to support clinical Manufacturing, Analytical Development, and Process Development., • This role requires close collaboration with internal and external partners—including Manufacturing, Process Development, Analytical Development, QA/QC and raw material suppliers—as well as internal stakeholders across, Finance, procurement Manufacturing, and Regulatory Affairs, to maintain supply continuity, regulatory compliance, and operational excellence. Duties/Responsibilities: • Manage an End-to-End inventory management program through collaboration with external partners (Contract Manufacturing Organizations, External Biorepositories, Raw Material suppliers)., • Manage a detailed End-to-End MRP process including the establishment of risk-based inventory targets., • Support the S&OP process through End-to-End supply planning and scenario analysis., • Support Raw Material risk assessment and Raw Material Qualification activities as part of BLA readiness activities., • Support the establishment of a supplier management program with external vendors., • Develop and maintain appropriate GMP controlled documents (i.e., SOPs, WIs, and Forms)., • Coordinate various temperature controlled non-clinical shipments of raw materials to support internal manufacturing., • Creation and management of PO’s in accordance to department budget and invoicing support., • Lead or support supplier/vendor selection, onboarding, and periodic performance/business reviews (scorecards, SLAs, corrective actions)., • Manage supplier quality agreements and change control notifications (e.g., raw material or CMO process changes) in partnership with Quality Assurance., • Own inventory accuracy activities — cycle counts, physical inventories, discrepancy investigations and CAPAs., • Support import/export and customs compliance for international raw material and drug substance/product shipments., • Track and report on key supply chain metrics (OTIF, lead times, inventory turns, days of supply) to leadership., • Participate in deviation/investigation and CAPA processes tied to supply chain or receiving issues (e.g., temperature excursions, damaged goods)., • Support tech transfer and scale-up activities by ensuring raw material/consumable supply readiness for new sites or processes., • Manage supplier risk mitigation planning (single-source risk, allocation, dual-sourcing strategies, safety stock)., • Partner with Finance on accruals, purchase price variance, and cost-savings initiatives., • Support internal and external audits/inspections (customer, regulatory) related to purchasing and inventory. Requirements: • Bachelor’s Degree in Life Sciences, Supply Chain Management, or related discipline; advanced degree preferred., • 8+ years of relevant experience in inventory management, planning, or supply chain in a biotech or pharmaceutical company, preferably in handling cell therapy or other similarly complex products., • Extensive quality and compliance background in a clinical GMP operational environment, including 3+ years prior experience in commercial or clinical GMP environment., • Ability to execute strategic objectives by focusing on critical near-term priorities while building toward long-term supply chain robustness for reliable delivery of complex treatments to patients., • Excellent analytical and problem-solving skills, with the ability to interpret complex data, make data-driven decisions, and clearly articulate business rationale and implications., • Excellent planning, coordination, and time management skills; you translate high level goals into plans, collaborate and adapt to meet objectives and timelines., • Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership., • A desire and ability to work in a dynamic, collaborative environment; you build productive and healthy relationships within and across functions., • Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; you share feedback and constructively challenge and accept challenges to generate the best ideas to advance project and company goals., • Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel., • Experience with GMP documentation practices (good documentation practices, deviation/CAPA systems)., • Proficiency in Excel/data analysis tools; experience building dashboards or reports, • Negotiation experience with suppliers on pricing, lead times, and contract terms. Preferred Qualifications: • Experience with Allogeneic Cell Therapy biotechnology companies., • ERP system experience (i.e. Netsuite)., • APICS/ASCM certification (CPIM, CSCP) or similar supply chain credential. Experience supporting BLA/regulatory filings or commercial launch readiness from a supply chain perspective. In addition to a great culture, we offer: • A beautiful facility, • An entrepreneurial, highly collaborative, and innovative environment, • Comprehensive benefits, including:, • Medical, Dental, and Vision, • Group Life Insurance, • Long Term Disability (LTD), • 401(k) Retirement Plan, • Employee Assistance Program (EAP), • Flexible Spending Account (FSA), • Paid Time Off (PTO), • Company paid holidays, including the year-end holiday week, • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $ 130,000 - $145,000 annually. Exact compensation may vary based on level, skills and experience.

Job Description The Vice President, Biometrics will lead and oversee all biometrics activities supporting clinical development from IND-enabling studies through regulatory submission. This role is responsible for Biostatistics, Statistical Programming, and Clinical Data Management, and will serve as the functional head of Biometrics at Janux. The VP will work closely with senior leadership to shape clinical strategy, study design, regulatory planning, and data-driven decision-making. This role requires a highly strategic and collaborative leader who can also operate hands-on in a dynamic, fast-paced clinical-stage biotech environment. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Provide strategic and operational leadership for the Biometrics function, including Biostatistics, Statistical Programming, and Clinical Data Management., • Build, lead, and develop a high-performing biometrics organization, including internal staff, consultants, and external partners (e.g., CROs and vendors)., • Lead biometrics strategy and execution across clinical development programs from early development through submission readiness and post-submission support., • Serve as the biometrics functional lead on cross-functional development teams, contributing to study design, statistical strategy, endpoint selection, and key development decisions., • Act as a trusted advisor to senior leadership on statistical methodologies, data strategy, data integrity, and clinical development planning., • Oversee the design, analysis, and interpretation of clinical trials and preclinical studies, ensuring scientific rigor, regulatory compliance, and high-quality data standards., • Provide oversight and strategic guidance for statistical analysis plans (SAPs), Tables, Listings, and Figures (TLFs), clinical study reports (CSRs), integrated summaries, and regulatory submission deliverables., • Ensure all biometrics deliverables meet applicable regulatory standards and industry best practices, including CDISC, SDTM, ADaM, and related requirements., • Support and lead preparation for regulatory interactions and inspections; represent Biometrics in meetings with FDA, EMA, and other global health authorities as appropriate., • Collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Translational Sciences, Pharmacovigilance, and Quality teams to ensure alignment on study design, execution, and data quality., • Provide oversight of CRO and vendor deliverables, including database build, CRF design, data review, programming outputs, and TLF production, ensuring quality, timelines, and cost-effectiveness., • Establish and maintain biometrics systems, standards, processes, and SOPs, including frameworks for CRF development, data collection, database management, and data governance., • Drive innovation in statistical methodology, adaptive trial design, data analytics, visualization, and technology-enabled processes to support program advancement and decision-making., • Ensure appropriate resourcing across the biometrics organization, including workforce planning, budget management, and vendor strategy., • Support business development, diligence, and strategic partnership activities as the biometrics subject matter expert., • Represent the company externally in scientific, regulatory, and industry forums, as appropriate.EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS, AND ABILITIES, • PhD in Biostatistics, Statistics, or a related quantitative discipline required., • 15+ years of experience in biotechnology or pharmaceutical drug development, including significant leadership experience in biometrics., • Proven experience leading integrated biometrics functions across Biostatistics, Statistical Programming, and Clinical Data Management., • Deep experience across all phases of drug development, ideally spanning early-stage development through registration and commercialization support., • Strong background in oncology therapeutics and drug development; experience in immunology, autoimmune disease, or related therapeutic areas is highly desirable., • Demonstrated success supporting regulatory submissions and health authority interactions, including NDA/BLA filings and advisory committee preparation., • Extensive knowledge of clinical trial design, statistical methodology, adaptive designs, and applicable regulatory requirements and guidance (ICH, FDA, EMA, GCP)., • Strong technical expertise, including familiarity with SAS, R, CDISC standards, electronic data capture systems, and modern clinical data platforms., • Proven ability to build, mentor, and scale high-performing teams in a collaborative and accountable culture., • Strong executive presence with excellent communication, presentation, and influencing skills, • Demonstrated ability to operate effectively in a fast-paced, hands-on, clinical-stage biotech environment with evolving priorities., • Strong organizational skills with the ability to manage multiple programs and deadlines simultaneously., • Commitment to scientific excellence, operational rigor, and continuous process improvement., • Ability to travel up to 25% as business needs require. In addition to a competitive base salary ranging from $330,000 to $360,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available. Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location. Benefits: • Annual bonus program, • Incentive stock option plan, • 401k plan with flat non-elective employer contribution, • Comprehensive medical insurance with 90-100% employer-paid premiums, • Dental and vision insurance, • HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity), • Unlimited PTO, • Generous holiday schedule; includes summer and winter company shutdown, • Relocation assistance Schedule: • Monday to Friday Work authorization: • United States (Required) Additional Compensation: • Annual targeted bonus % Work Location: • Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 25% for meetings or site visits as required. Travel: • Up to 25% travel may be required, including domestic and occasional international travel for regulatory meetings, CRO oversight, investigator meetings, scientific conferences, and corporate activities. EQUAL OPPORTUNITY EMPLOYER: Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Country United States Shift 1st Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Job Summary The Head of Quality and Regulatory Affairs is responsible for developing, coordinating and implementing quality and regulatory strategies and quality programs required for the development, regulatory approval, successful manufacture, commercialization, and post-market surveillance of Autoimmunity products. Responsible for interacting, influencing and collaborating with all levels of the organization. This position serves as the company’s senior advisor, implementer and administrator for all regulatory strategies, regulatory compliance, quality systems programs and quality training; also serves as the Management Representative, Person Responsible for Regulatory Compliance (PRRC per IVDR) and HIPAA Privacy Officer. In conjunction with the CEO, creates policies to maintain compliance with legal and regulatory requirements. Provides leadership and development to assigned teams and staff. Serves as a member of the Autoimmunity Executive Team. Key Accountabilities • Works closely with the COO, provides information on the status of product quality, customer satisfaction, opportunities for quality improvement, process simplification and the capability of the Quality System., • Ensures processes and procedures are in place to investigate and resolve customer complaints to the customer’s satisfaction in a timely manner. Ensures all root causes of customer dissatisfaction are determined and that processes are improved to prevent reoccurrence., • Ensures total customer satisfaction is a priority of employees by working closely with the management team and through personal leadership skills., • Ensures timely completion of QC product testing and QA product release dispositions., • Ensures appropriate stability studies are conducted to support new products, shelf life extensions, and any additional stability studies for international registration., • Provides leadership for special projects in Quality Assurance, Quality Control, Complaint Handling and Regulatory Affairs., • Oversees preparation of technical dossiers for CE Mark product, regulatory Canadian submissions and other international registration documentation and works in partnership with distributors and/or affiliates by providing to them appropriate documentation to obtain international product registrations., • Handles any regulatory reporting needs such as product corrections, removals, recalls and MDR Reporting and vigilance activities., • Manages the quality and regulatory staff and departmental resource needs. This includes but is not limited to, interviewing, hiring and training employees; planning, assigning and supervising work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Creates and leads high-performing, innovative, management teams that attracts, recruits, develops and retains exceptional staff., • Provides leadership and management to ensure that the mission and core values of the company are put into place., • Creates a culture of compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality Systems regulations (QSRs), as well as applicable Environmental Health & Safety, Human Resources, HIPPA and other regulatory and administrative policies., • Reflects the Werfen’s Values as a role model to employees, customers, and business partners. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key relationships • Research & Development teams, • Manufacturing and Operations teams, • Marketing Team, • Finance Team, • Werfen Sr. Quality & Regulatory Managers, Affiliates & Distributors Education: • Bachelor’s degree life sciences or related field required, advanced degree in Quality or Regulatory strongly preferred. Experience: • At least ten (10) years Quality & Regulatory corporate leadership experience, within the medical device industry required., • Demonstrated experience leading organizational change required, within a regulated industry. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: • Quality, regulatory and in vitro diagnostics/medical devices industry experience required, with extensive knowledge of strategic planning, US and worldwide regulations, quality and regulatory processes and experience interfacing with regulatory bodies, such as FDA, Notified Bodies and Competent Authorities required., • Excellent knowledge of Quality Systems Regulations, Product Change Requests and ISO regulations as they apply to device manufacturing required., • Extensive experience interfacing with FDA and/or ISO, MDSAP auditors required., • Excellent working knowledge of statistics, teamwork environments, workplace safety and complaint handling systems required., • Outstanding verbal and written skills, utilizing critical thinking and organizational talents are required., • Track record of success at building and leading high performing, complex teams. The annual base salary range for this role is currently $240,000–$280,000 annually. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus. 25% 25% or more, includes international travel Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. #J-18808-Ljbffr

Job Summary The Head of Quality and Regulatory Affairs is responsible for developing, coordinating and implementing quality and regulatory strategies and quality programs required for the development, regulatory approval, successful manufacture, commercialization, and post-market surveillance of Autoimmunity products. Responsible for interacting, influencing and collaborating with all levels of the organization. This position serves as the company’s senior advisor, implementer and administrator for all regulatory strategies, regulatory compliance, quality systems programs and quality training; also serves as the Management Representative, Person Responsible for Regulatory Compliance (PRRC per IVDR) and HIPAA Privacy Officer. In conjunction with the CEO, creates policies to maintain compliance with legal and regulatory requirements. Provides leadership and development to assigned teams and staff. Serves as a member of the Autoimmunity Executive Team. Key Accountabilities • Works closely with the COO, provides information on the status of product quality, customer satisfaction, opportunities for quality improvement, process simplification and the capability of the Quality System., • Ensures processes and procedures are in place to investigate and resolve customer complaints to the customer’s satisfaction in a timely manner. Ensures all root causes of customer dissatisfaction are determined and that processes are improved to prevent reoccurrence., • Ensures total customer satisfaction is a priority of employees by working closely with the management team and through personal leadership skills., • Ensures timely completion of QC product testing and QA product release dispositions., • Ensures appropriate stability studies are conducted to support new products, shelf life extensions, and any additional stability studies for international registration., • Provides leadership for special projects in Quality Assurance, Quality Control, Complaint Handling and Regulatory Affairs., • Oversees preparation of technical dossiers for CE Mark product, regulatory Canadian submissions and other international registration documentation and works in partnership with distributors and/or affiliates by providing to them appropriate documentation to obtain international product registrations., • Handles any regulatory reporting needs such as product corrections, removals, recalls and MDR Reporting and vigilance activities., • Manages the quality and regulatory staff and departmental resource needs. This includes but is not limited to, interviewing, hiring and training employees; planning, assigning and supervising work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Creates and leads high-performing, innovative, management teams that attracts, recruits, develops and retains exceptional staff., • Provides leadership and management to ensure that the mission and core values of the company are put into place., • Creates a culture of compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality Systems regulations (QSRs), as well as applicable Environmental Health & Safety, Human Resources, HIPPA and other regulatory and administrative policies., • Reflects the Werfen’s Values as a role model to employees, customers, and business partners. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key relationships • Research & Development teams, • Manufacturing and Operations teams, • Marketing Team, • Sales Team, • Finance Team, • Werfen Executive Leadership, • Werfen Sr. Quality & Regulatory Managers, Affiliates & Distributors Minimum Knowledge & Experience: Education: • Bachelor’s degree life sciences or related field required, advanced degree in Quality or Regulatory strongly preferred. Experience: • At least ten (10) years Quality & Regulatory corporate leadership experience, within the medical device industry required., • Demonstrated experience leading organizational change required, within a regulated industry. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: • Quality, regulatory and in vitro diagnostics/medical devices industry experience required, with extensive knowledge of strategic planning, US and worldwide regulations, quality and regulatory processes and experience interfacing with regulatory bodies, such as FDA, Notified Bodies and Competent Authorities required., • Excellent knowledge of Quality Systems Regulations, Product Change Requests and ISO regulations as they apply to device manufacturing required., • Extensive experience interfacing with FDA and/or ISO, MDSAP auditors required., • Excellent working knowledge of statistics, teamwork environments, workplace safety and complaint handling systems required., • Outstanding verbal and written skills, utilizing critical thinking and organizational talents are required., • Track record of success at building and leading high performing, complex teams. The annual base salary range for this role is currently $240,000–$280,000 annually. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus. Travel requirements: 25% 25% or more, includes international travel Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com #J-18808-Ljbffr

Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma and haemato-oncological malignancies. Pfizer’s in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. • The Medical Affairs AI Innovation Director will report into the Oncology AI Innovation Head, • This is a vital role within the Pfizer Oncology organization, acting as an operational business partner across Oncology Medical, International Medical Affairs and Pfizer US (Medical Platforms) for all Artificial Intelligence (AI) and digital innovation related initiatives., • The successful candidate will be a health technology solutions leader passionate about the potential of AI and digital innovation to transform how Medical can help breakthrough oncology therapies alter clinical practice and transform cancer patients’ outcomes., • The incumbent will help to embed a digital AI-first mindset and culture across Oncology Medical teams, enable internal and external collaboration around Medical use cases of AI digital innovation initiatives and lead on external engagement to identify, evaluate, and secure AI digital innovation opportunities for Oncology Medical., • They will be responsible for implementing AI digital innovation use cases within Oncology Medical and collaborating with AI Innovation colleagues in other parts of Pfizer to drive forward the digital first agenda across the organization. Example use cases include improved medical landscape sensing, Medical Strategy deliverable production process improvements, Field Medical excellence analytics and Medical content personalization, etc., • It is expected that these efforts will provide direct and visible benefits to Pfizer Oncology Medical process efficiency, Medical Strategy generation and execution, and Field Medical effectiveness in the near-, mid-, and long-term., • Support the Oncology AI Innovation Head and Oncology Medical leaders in identifying and articulating opportunities for digital technologies/transformation to enhance the effectiveness of global Oncology Medical strategy deliverable development execution and US Field Medical effectiveness., • Lead as an AI Subject Matter Expert within Oncology Medical, championing AI and innovative technology to achieve goals, inform medical decisions and drive future access for patients in a faster and HCP/patient centric manner., • Maintain current knowledge of technology trends and industry solutions with relevance to Medical Strategy and Affairs via market intelligence and strategic vendor partnerships. Work closely with Pfizer Oncology (especially Medical and Oncology Scientific Affairs and Strategic Partnerships) and other enterprise teams to identify emerging external AI/digital innovations and technologies., • Support execution against Pfizer Oncology Medical’s AI breakthrough goals including managing cross-functional teams across Pfizer Oncology Medical, International Medical Affairs, and Pfizer Us (Medical Platforms) including budget monitoring, KPI’s and successful deployment in partnership with Digital., • Support the Oncology AI Innovation Head in developing business case / ROI expectations for above innovation opportunities (in partnership with Business Development where relevant) and work with Oncology Medical departmental leaders, Pfizer US (Medical Platforms) colleagues and the Pfizer Oncology LT to obtain Oncology and wider enterprise endorsement and funding for the proposed innovations., • Collaborate with colleagues across Pfizer Oncology (especially Medical and Oncology Scientific Affairs and Strategic Partnerships), International Medical Affairs, Pfizer US (Medical Platforms) and the broader business, including interacting with machine learning (ML) professionals, data scientists and programmers within AI/Data COEs to lead the implementation of novel AI-enabled Oncology Medical approaches and/or strategic initiatives that enhance the effectiveness of global Oncology Medical strategy deliverable development / execution and US Field Medical effectiveness, as well as providing strategic insight into programs., • Support colleagues across Oncology Medical with innovative data/AI/ML solutions to complement and reorganize existing practices - including Identifying recent developments in AI research that may impact Oncology R&D., • Support Field Medical excellence through the enablement of AI-driven insight analytics, • Manage lifecycle of AI digital solutions from concept design, prototyping, to development and release. Work with R&D IT teams to identify and manage data security risks and GxP validation requirements for digital technologies., • Serve as Pfizer representative to strategic Medical-relevant AI/digital partnerships with external organizations, healthcare institutions, and tech companies to leverage AI capabilities and stay at the forefront of innovation., • Measure and demonstrate tangible business impact of AI solutions and analyzing data to assess ROI and making data driven decisions to optimize AI strategies for maximum value creation., • Drive awareness among Medical teams of the value created / ROI from oncology development-focused AI/digital technological innovation, and work with Oncology Scientific Affairs and Strategic Partnerships colleagues on external communications on these topics., • Bachelor’s Degree in computer science (or related field) with 10+ years experience in implementation of AI/ML/DL-driven strategies. Deep insights into the biotech / healthcare AI/digital environment/ecosystem., • 5+ years’ experience in driving cross functional teams to develop AI solutions aligned with business goals for maximum impact and successful delivery., • 5+ years’ experience in leading AI digital innovation strategies and implementation in the biotech / pharmaceutical R&D or Medical field., • Passionate about the application of AI/Gen-AI in healthcare to transform patient outcomes and care., • Experience acting as an interface between business and technical delivery teams to originate and implement novel forms of analytics and manage cross-functional innovation projects., • Excellent communication, presentation, and interpersonal skills., • Ability to work within a matrix organization and collaborate effectively across functions (e.g., R&D, Commercial and IT), • Strong demonstrated skills in relevant capabilities such as product development, ecosystem activation, etc., • Experience working in the Oncology therapeutic area., • Experience working in Medical Strategy and/or Affairs., • Experience working with Design Thinking processes., • Strong technical skills including applying and developing methods of algorithms in AI, data sciences best practices, problem solving and analytical thinking., • Demonstrated success in developing and executing AI and innovation strategies within biopharmaceutical industry or a similarly highly regulated setting. The annual base salary for this position ranges from $161,600.00 to $269,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. #J-18808-Ljbffr

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.comAs guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function: Animal MedicineJob Category:People LeaderAll Job Posting Locations:San Diego, California, United States of America, Spring House, Pennsylvania, United States of AmericaJob Description:About Innovative MedicineOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.Learn more at We are searching for the best talent for a Global Associate Director, Veterinary Oversight to be located in Spring House, PA or La Jolla, CA.Purpose: The Global Associate Director, Veterinary Oversight provides global strategic and operational leadership for veterinary oversight across in vivo research programs and serves as the designated Attending Veterinarian for assigned sites and programs. This role is accountable for the scientific, ethical, and regulatory integrity of veterinary oversight for internal research activities and partners with designated accountable leaders to provide veterinary oversight input for external, contracted non-clinical and GLP safety assessment studies, supporting consistent veterinary standards, animal welfare practices, and regulatory compliance across global internal sites and external partners.You will be responsible for: Serving as the designated Attending Veterinarian (AV) with authority for the adequacy of veterinary care and animal welfare programs, providing independent veterinary oversight to ensure animal well‑being, appropriate medical care, and application of humane endpoints in accordance with applicable regulations and institutional policies.Advising institutional Officials, IACUCs/ECs, and senior leadership on matters related to animal care and welfare, and ensure AV responsibilities are appropriately delegated, documented, and maintained across sites and programs.Providing global leadership and strategic direction for veterinary oversight supporting discovery research and nonclinical development programs, aligning veterinary strategy with business priorities, scientific objectives, and regulatory expectations.Directly managing, mentoring, and developing clinical veterinarians, ensuring consistent performance, capability development, and succession planning across geographically dispersed teams.Establishing, harmonizing, and maintaining global veterinary standards, expectations, and best methods across internal sites and external partners.Ensuring the highest standards of animal welfare and veterinary oversight across internal vivaria, including oversight of preventative medicine, diagnostics, quarantine/acclimation, surgical support, and veterinary care programs.Supporting IACUC/EC activities, including protocol review, post‑approval monitoring, inspections, audits, and regulatory interactions, to ensure compliance with applicable USDA, EU directives, FDA regulations, GLP requirements, AAALAC standards, and internal policies.Partnering with study teams, Animal Welfare & Regulatory Compliance, Quality, Legal, and other partners to address veterinary and animal welfare findings, risks, or issues.Providing veterinary consultation and oversight input for externally conducted GLP safety assessment studies, including review of study designs, animal monitoring plans, humane endpoints, and veterinary care provisions, in collaboration with accountable study and vendor oversight functions.Collaborating with toxicologists, study directors, QA, and procurement to support CRO veterinary programs, as applicable.Contributing veterinary input, when applicable, to the qualification, auditing, and ongoing oversight of animal suppliers and contract research organizations.Partnering with training teams to establish global expectations for veterinary training and competency, and promote consistent application of the 3Rs, refinement strategies, and humane endpoint criteria across internal and external programs.Leading global quality improvement initiatives related to veterinary oversight and animal welfare, and maintain awareness of emerging regulations, scientific advances, and best methods in laboratory animal medicine and toxicology oversight.Qualifications/RequirementsEducation:A Doctorate of Veterinary Medicine/VMD (DVM/VMD) or equivalent degree from an accredited school of Veterinary Medicine is required.Licensed (or license-eligible) to practice veterinary medicine in the United States and/or European Union, with ability to meet regional requirements is required.ACLAM, ECLAM, or equivalent board certification is strongly preferred.Experience and Skills:Required: Minimum of eight (8) years’ experience in laboratory animal medicine within biotech/pharma or CRO environments is required.Education and experience sufficient to independently fulfill Attending Veterinarian responsibilities is required.Demonstrated experience in clinical veterinary care, animal welfare, and 3Rs advancement is required.Proven experience providing veterinary oversight, including for GLP safety assessment studies is required.Deep understanding of regulatory frameworks (USDA, EU Directive 2010/63, GLPs) and AAALAC standards is required.Outstanding communication and interpersonal skills with a high level of diplomacy is required.Strong collaboration and professional relationship management capabilities are required.Ability to lead cross-functional teams and drive performance of geographically dispersed teams is required.Comfort engaging with partners at all organizational levels to communicate compliance expectations and address concerns/issues is required.Active participation in industry organizations and ongoing professional development is required.Strong analytical, problem-solving, and decision-making skills are required.Excellent judgment and influencing skills across functions and regions is required.Ability to operate effectively in a matrixed global organization is required.Commitment to continuous professional development and regulatory awareness is required.Adept at working under time constraints and leading changing priorities to achieve results effectively is required.Must complete all annual training requirements.Must perform all work per appropriate safety standards. Ability to wear all Personal Protective Equipment required to perform work tasks is required.Applicable vaccinations may be required for entry and work within specific laboratory and vivarium spaces.Preferred:Hands-on nonclinical toxicology experience, including study design and data interpretation is preferred.Experience working with large, complex international teams is preferred.Background in project management and organizational change is preferred.Other:Domestic and international travel required; up to 20%.Availability for off-core business hours meetings and work as needed.This is an essential personnel role: Essential Personnel are defined as the staff who are required to report to their designated work location, to ensure the operation of essential functions or departments during an emergency, as determined by Johnson & Johnson, or when the business has suspended operations. There are some individuals who may be required to perform essential services remotely and those individuals will be identified in advance and notified by their supervisors, but in most cases Essential Personnel are required to be on-site during an emergency or suspension of operations.The expected base pay range for this position is $137,000 to $235,750.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits:Vacation –120 hours per calendar yearSick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childCondolence Leave – 30 days for an immediate family member: 5 days for an extended family memberCaregiver Leave – 10 daysVolunteer Leave – 4 daysMilitary Spouse Time-Off – 80 hoursAdditional information can be found through the link below.For additional general information on Company benefits, please go to:The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.This job posting is anticipated to close on 05/28/2026. The Company may, however, extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.#LI-OnsiteRequired Skills:Preferred Skills:Animal Management, Collaborating, Developing Others, Drug Discovery Development, Inclusive Leadership, Industry Analysis, Leadership, Preclinical Research, Regulatory Affairs Management, Research Ethics, Researching, Resource Planning, Scientific Research, Stakeholder Engagement, Standard Operating Procedure (SOP), Veterinary Medicine, Veterinary Sciences, Vivarium ManagementThe anticipated base pay range for this position is :$137,000.00 - $235,750.00Additional Description for Pay Transparency:SummaryLocation: Spring House, Pennsylvania, United States of America; San Diego, California, United States of AmericaType: Full time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.comAs guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: Project/Program Management GroupJob Sub Function: Project/Program ManagementJob Category:ProfessionalAll Job Posting Locations:Cambridge, Massachusetts, United States of America, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of AmericaJob Description:About ImmunologyOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.Learn more at This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; Cambridge, MA; La Jolla, CA; Beerse, Belgium; Leiden, Netherlands; High Wycombe, UK; Allschwil, Switzerland; or Cork, Ireland. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):Spring House, PA or Horsham, PA or Titusville, NJ or Raritan, NJ or Cambridge, MA or La Jolla, CA - Requisition Number: R-075620Beerse, BE or Leiden, NL or Cork, IE - Requisition Number: R-076539High Wycombe, UK- Requisition Number: R-076543Allschwil, CH - Requisition Number: R-076545Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.We are searching for the best talent for Senior Manager, Regulatory Program Management, Immunology.Purpose:The Regulatory Program Manager (RPM) will be an asset-level operational leader, driving projects forward through the translation and distillation of overall global regulatory strategy to executable plans and the coordination of cross-functional team efforts. The RPM will serve as the primary project management point of contact to ensure Regulatory functional plans are aligned with compound/program objectives and commitments. RPMs will work closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as Project Management, Medical Writing, Clinical and other key functions to ensure confidence, quality, and speed in the delivery of the Johnson & Johnson Innovative Medicine (JJIM) portfolio. The RPM is guided in all matters by the Johnson & Johnson Credo and held to Johnson & Johnson Leadership Performance Standards.This RPM role is part of the Immunology Delivery Unit and aligned with JJIM’s organizational and portfolio support structure.The Sr. Manager, RPM, will be deployed in support of JJIM’s most complex programs, called on to lead critical department initiatives and may represent the function with organizational leadership and in larger capability enhancement efforts at cross-functional and organizational levels. This individual will be expected to provide coaching, education and mentoring to more junior staff and select team efforts, while driving continuous enhancement of RPM impact for the organization.Principal Responsibilities:Empower teams to deliver the highest possible impact for our programs, business, and patients around the world.Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand what is critical at any one time, proactively identify and mitigate risks, and exploit meaningful opportunities for acceleration. (e.g., MSP project plan, risk and opportunity playbooks, scenario evaluation, and business case development).Lead operations with Global Regulatory Team (GRT), including activities such as ensuring visibility to and/or management of worldwide submissions, driving processes to optimize global filing and launch sequencing, pre and post-submission activities, preparation for health authority meetings and additional major regulatory milestones.Provide strong operational leadership to Regulatory and program teams, providing scenario and visualization support driving rapid and informed decision making, challenging status quo, and fostering impactful innovation.Support the Global Regulatory Team (GRT) in a manner that fosters and maintains a high-performance team culture, facilitating GRT, Submission Working Group, Rapid Response Team meetings, and similar as required.Ensure coordination of critical regulatory information and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team including co-development partners and/or other external partners, as required. Liaise with Compound Development Team (CDT) and Senior Leadership Team (SLT) partners to prepare discussions and drive meeting outcomes.Lead the operational execution of select marketing applications including clinical variations and Pediatric submissions, partnering to ensure alignment of Regulatory and compound submission strategies, developing clear and detailed submission plans, ensuring team roles, responsibilities and accountabilities, and positioning teams to proactively mitigate risks and enhance opportunities.Drive process improvements and embed best practices from across programs, TAs, and functions into supported teams.Act as operational owner of the Global Filing and Launch Strategy.Work across functions and organizational boundaries to establish processes and procedures and new innovative methods that improve overall delivery.Build RPM value proposition through continuous refinement of delivery, prioritizing and focusing on areas of highest impact and opportunity, and actively leading efforts to enable enhanced capabilities and impacts.Serve as a mentor and coach to other RPMs and team members. As required, work with standard budgeting and forecasting process and reporting tools to build and maintain the regulatory components and health authority budget to an overall coordinated project plan in Planisware.Support and facilitate activity, resource, and cost planning across the R&D project portfolio, as required.Qualifications:A minimum of a Bachelor’s degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs, or a related discipline. Advanced degree preferred. A minimum of 7 years’ experience of industry/business is required.A minimum of 3 years of experience in a Pharmaceutical, MedTech or comparable R&D area is required.Experience in strategic planning and development of regulatory strategy, and cross-functional management of global regulatory submissions and processes (e.g., NDA, MAA, and lifecycle documents) across various phases of the drug development cycle is required.Project management experience leading global regulatory teams in a matrix setting is required.Experience leading submission teams and working with external partners is preferred.Demonstrated experience conducting business process, scenario, and critical path analysis on complex projects with accelerated timelines required.Knowledge of global regulations, guidelines, and regulatory requirements with in-depth knowledge/focus of FDA/EMA procedures is required.Demonstrated understanding of Global Regulatory Affairs processes is required.Proficiency and demonstrated application of project management standards, planning and visualization methods/tools is required.Project management certification preferred.Regulatory certification (RAC) preferred.Proficiency with Microsoft Project is highly preferred.Must have excellent verbal and written communication skills.Must have strong innovative and strategic thinking skills.The ability to drive and expedite team decision-making and translate strategy to clear, executable action plans is required.The ability to resolve controversy and influence teams without formal authority is required.The ability to influence decision-making at all levels and represent project teams with senior leadership and governance bodies is required.This position will require up to 10% domestic and international travel.This job posting is anticipated to close on May 22, 2026. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.#LI-HybridRequired Skills:Preferred Skills:Agile Decision Making, Agility Jumps, Analytics Insights, Business Alignment, Continuous Improvement, Cross-Functional Collaboration, Leadership, Organizational Project Management, Organizing, Program Management, Project Management Methodology (PMM), Project Management Office (PMO), Project Management Tools, Project Reporting, Statement of Work (SOW), Technical CredibilityThe anticipated base pay range for this position is :$122,000.00 - $212,750.00Additional Description for Pay Transparency:Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Company’s long-term incentive program.Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:Vacation –120 hours per calendar yearSick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefitsSummaryLocation: Raritan, New Jersey, United States of America; Horsham, Pennsylvania, United States of America; Cambridge, Massachusetts, United States of America; Titusville, New Jersey, United States of America; Spring House, Pennsylvania, United States of America; San Diego, California, United States of AmericaType: Full time

Sony Electronics Inc. is looking for the risk-takers, the collaborators, the inspired and the inspirational. We want the people who are brave enough to work at the cutting edge and create solutions that will enrich and improve the lives of people across the globe. In addition to competitive pay and benefits, we offer an environment and culture that promotes Diversity, Equity and Inclusion. In addition, our team members enjoy innovative work-life balance opportunities including a hybrid home/office workplace, monthly "Free Fridays", and early shutdowns on Fridays throughout the year (including half-days during the summer). Join us on our mission to fill the world with emotion through the power of creativity and technology. The Senior Packaging and Product Compliance Specialist is primarily responsible to monitor the development of environmental packaging laws and regulations in the U.S. and Canada, and to represent the company's perspective through industry platforms. Additionally, this role will analyze requirements, develop and implement compliance assurance programs for the company in collaboration with various internal stakeholders, and manage the company's obligations including registration, reporting and compliance fees management. Primary focus is on product packaging and printed material extended producer responsibility (EPR) requirements, while also supporting chemical requirements as well as internal compliance review processes for various locally-planned projects. Responsibilities • Collect information related to the development of laws and regulations, assess the impact to the company, share them with internal stakeholders and develop the company's position. Primary focus will be on extended producer responsibility, labeling, and recycled content restrictions for packaging while also supporting chemical restrictions and reporting requirements for products and packaging., • Participate in trade associations and other platforms to share the company's perspectives and represent company's interest around proposed changes in requirements., • Develop compliance assurance programs and procedures to address upcoming changes through partnerships with the internal compliance department at headquarters to ensure that the company's products are designed and packaged in accordance with the new requirements., • Assess the financial impact of upcoming changes and develop or update the financial management process to account for future changes. Monitor and manage cost(s) of compliance., • Register and report required compliance data with various authorities by working with HQ and business group compliance team(s) with support from the environmental compliance data analyst. Arrange and ensure completion of data validation., • Identify opportunities around packaging for cost reduction as well as sustainability leadership toward the company's long term environmental commitment with Road to Zero environmental plan. Drive changes toward sustainable packaging and cost reduction where feasible., • Support the internal compliance approval process for locally planned projects by reviewing various applications and assisting business planners., • Assist various internal groups and Sony group companies as a subject matter expert for packaging and printed material EPR. Our ideal candidate is highly self-motivated, detailed oriented, and committed to timely deliverables. Minimum Requirements • Bachelor's degree in Environmental Science, Environmental Policy, Regulatory Affairs, or a related field., • 5+ years of experience in environmental product compliance, environmental stewardship, regulatory affairs, or a related field., • Strong understanding of environmental regulations and their impact on business operations., • Ability to analyze regulatory requirements and standards, assess compliance risks, and translate findings into business implications., • Strong problem-solving skills and ability to address compliance challenges., • Excellent verbal and written communication skills, with the ability to convey complex regulatory information to diverse stakeholders., • Strong project management, data analysis, and stakeholder management skills., • Ability to manage multiple priorities and projects in a fast-paced environment with minimal supervision., • Highly motivated and proactive in monitoring and responding to regulatory developments., • Proficiency with Microsoft Office applications, including Excel, Outlook, Word, and PowerPoint. Preferred Skills • Experience in the electronics industry., • Familiarity with local, national, and international packaging and chemical regulations., • Experience developing and implementing solutions to environmental compliance challenges., • Experience with Power BI, SAP, BW, and/or Smartsheet. The anticipated base pay range for this position is $84,014 to $112,017. The actual base salary offered depends on a variety of factors, which may include as applicable, the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. In addition to a competitive base salary, this position is also eligible for an annual corporate bonus plan, which is based on company performance and is not guaranteed, and a comprehensive benefits package including healthcare benefits (medical, dental, and vision), paid medical leave, a 401k plan with matching company contributions, vacation time, education assistance, student loan assistance program, eighty hours of paid sick leave time annually, and up to twelve weeks paid parental leave. Sony Electronics is an Equal Opportunity Employer that values employees with a broad cross-cultural perspective. We strive to create an inclusive environment, empower employees and embrace diversity. We encourage everyone to respond. All applicants will receive fair and impartial treatment without regard to race, color, religion, sex, national origin, ancestry, citizenship status, age, legally protected physical or mental disability, protected veteran status, status in the U.S. uniformed services, sexual orientation, gender identity or expression, marital status, genetic information or on any other basis which is protected under applicable federal, state or local law.

Job SummaryPosition Overview: The Senior Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory registrations and submissions activities including working with Marketing, New Product Development, Manufacturing and Engineering. Responsibilities: • Support initiatives to ensure regulatory approval of medical devices in both domestic and international markets. Provide regulatory affairs support for all aspects of product development, product manufacturing, and/or clinical studies including pre-market, post-market and physician initiated studies. Provide Regulatory support to on-going compliance and corporate initiatives.• Partner with Marketing and Development teams to provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.• Compile and submit documentation as required in support of marketing initiatives. Review marketing and sales promotional materials for regulatory impact, including:• Promotional materials for journals and other media• Trade show booths, materials for distribution• Sales talking points, etc.• Review product packaging and labeling changes for regulatory impact, including:• US labels in English• Review of translations with certified translators• Vendor documentation, certification, and fitness for quality• Represent Regulatory Affairs on project teams and in key meetings and decision making processes regarding labeling and promotion.• Assist with pre-market and post-market filings (510(k), IDE, PMA, PMA updates, CE Marking, Canadian Registrations, EU Registrations, and ROW registrations).• Prepare submissions and reports for FDA and support other international agencies as required. Review submission decisions/content issues with manager.• Provide assistance in planning, creating, organizing and interpreting regulatory documents for submission to various regulatory agencies.• Review and approve project documentation such as specifications, procedures, schedules, test protocols and reports, validations, etc.• Evaluate, communicate, and present change assessments to the organization to ensure timely implementation in support of continued compliance. Review, evaluate and approve Engineering Change Orders (ECO) especially those concerning significant changes and revisions.• Performs other duties as required.Education and Experience:• B.S. / B.A. or equivalent combination of education and experience.Minimum Requirements:• 5+ years of regulatory medical device industry experience.• RAC Certification preferred.• Knowledge of regulatory guidelines and requirements (domestic and international). Preferred Skills and Competencies: • Effective verbal and written communication skills• Experience with reviewing ECOs, Requirements, and Specification Documents.• Understanding of 21 CFR 820, CMDR, ISO 13485, MDD.• Team player ready to work hard on a dedicated team that has the safety of the patient as priority #1.• Ability to communicate at multiple levels of an organization.• PC skill, word processing, spreadsheet, database, specifically: Word, Excel, PowerPoint, Visio, Project.• Ability to organize and manage multiple priorities.• Ability to generate and maintain accurate records. Position Overview:The Senior Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory registrations and submissions activities including working with Marketing, New Product Development, Manufacturing and Engineering.Responsibilities:• Support initiatives to ensure regulatory approval of medical devices in both domestic and international markets. Provide regulatory affairs support for all aspects of product development, product manufacturing, and/or clinical studies including pre-market, post-market and physician initiated studies. Provide Regulatory support to on-going compliance and corporate initiatives.• Partner with Marketing and Development teams to provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.• Compile and submit documentation as required in support of marketing initiatives. Review marketing and sales promotional materials for regulatory impact, including:• Promotional materials for journals and other media• Trade show booths, materials for distribution• Sales talking points, etc.• Review product packaging and labeling changes for regulatory impact, including:• US labels in English• Review of translations with certified translators• Vendor documentation, certification, and fitness for quality• Represent Regulatory Affairs on project teams and in key meetings and decision making processes regarding labeling and promotion.• Assist with pre-market and post-market filings (510(k), IDE, PMA, PMA updates, CE Marking, Canadian Registrations, EU Registrations, and ROW registrations).• Prepare submissions and reports for FDA and support other international agencies as required. Review submission decisions/content issues with manager.• Provide assistance in planning, creating, organizing and interpreting regulatory documents for submission to various regulatory agencies.• Review and approve project documentation such as specifications, procedures, schedules, test protocols and reports, validations, etc.• Evaluate, communicate, and present change assessments to the organization to ensure timely implementation in support of continued compliance. Review, evaluate and approve Engineering Change Orders (ECO) especially those concerning significant changes and revisions.• Performs other duties as required.Education and Experience:• B.S. / B.A. or equivalent combination of education and experience.Minimum Requirements:• 5+ years of regulatory medical device industry experience.• RAC Certification preferred.• Knowledge of regulatory guidelines and requirements (domestic and international).Preferred Skills and Competencies:• Effective verbal and written communication skills• Experience with reviewing ECOs, Requirements, and Specification Documents.• Understanding of 21 CFR 820, CMDR, ISO 13485, MDD.• Team player ready to work hard on a dedicated team that has the safety of the patient as priority #1.• Ability to communicate at multiple levels of an organization.• PC skill, word processing, spreadsheet, database, specifically: Word, Excel, PowerPoint, Visio, Project.• Ability to organize and manage multiple priorities.• Ability to generate and maintain accurate records.NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-HybridAdditional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $91,700.00 - $137,525.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.(Know Your Rights)SummaryLocation: US - Massachusetts; US - California (San Diego - Office)Type: Full time

Qualcomm's Export & Sanctions Compliance Department is seeking a Senior Export Compliance Specialist to take a lead role in Qualcomm's US export licensing program, preparing and submitting license applications in support of global operations. We are looking for an experienced professional that is meticulous, detailed orientated, and highly organized. Knowledge of the US Export Administration Regulations (EAR) and Bureau of Industry and Security (BIS) procedures required. Responsibilities Include: • Draft and submit deemed export license applications under the EAR., • Draft and submit technology export license applications under the EAR., • Perform export license determination by ECCN and destination country., • Determine applicable license exceptions under the EAR by ECCN and destination country., • Ensure exports comply with license terms, including riders and conditions., • Manage the full lifecycle of export license, including tracking and management., • Perform audits of export licenses to ensure compliance., • Report on program status details for management., • Conduct internal reviews of processes, corrective actions, and training as required., • Develop and maintain processes, guidelines, and training to support export licensing., • Collaborate with cross-functional teams across global operations. Minimum Qualifications: Bachelor's degree and 3+ years of Export or Sanctions Compliance, International Affairs, or related work experience. OR Associate's degree in Business Administration/Management, International Business, Law, Electronic/Telecom Engineering, or related field and 5+ years of Export or Sanctions Compliance, International Affairs, or related work experience. OR High School Diploma or equivalent and 7+ years of Export or Sanctions Compliance, International Affairs, or related work experience.*Completed advanced degrees in a relevant field may be substituted for up to two years (Master's = one year, Doctorate = two years) of work experience. Preferred Qualifications: • Minimum 5 years of experience in export compliance, including at least 2 years focused on export licensing programs., • Proven experience in managing export license programs, including:, • Drafting and submitting export license applications., • Reviewing/approving proposed license riders and conditions., • Ensuring compliance with export license terms both individuals and business units., • Monitoring and maintaining existing licenses, including expirations, extensions, reporting and replacements., • Strong knowledge of EAR and BIS licensing procedures., • Bachelor's degree in international business, engineering, management, finance, or a related field, or equivalent work experience., • Will consider candidates with equivalent experience in other areas of export & sanctions compliance (i.e. ECCN classification)., • Knowledge and experiences on Microsoft Team, SharePoint, Salesforce, Database design and management., • Desire to advance within the Export & Sanctions Compliance Department and take on additional responsibilities., • Familiarity with the EAR, including sections 740, 742, 750 and others related to export licensing and exporting under a license., • Additional knowledge of including anti-boycott regulations, sanctions administered by the Office of Foreign Assets Control (OFAC), and the International Traffic In Arms Regulations (ITAR)., • Strong verbal and written communication skills., • Strong computer skills including ability to research partners and prepare reports in Excel, SharePoint, Salesforce, and Trade Export systems, and quickly learn new software tools., • Ability to work at both detailed and strategic levels, work calmly under pressure and with frequent interruptions, and display sound judgment. Pay range and Other Compensation & Benefits : $76,000.00 - $114,000.00 The above pay scale reflects the broad, minimum to maximum, pay scale for this job code for the location for which it has been posted. Even more importantly, please note that salary is only one component of total compensation at Qualcomm. We also offer a competitive annual discretionary bonus program and opportunity for annual RSU grants (employees on sales-incentive plans are not eligible for our annual bonus). In addition, our highly competitive benefits package is designed to support your success at work, at home, and at play. Your recruiter will be happy to discuss all that Qualcomm has to offer and you can review more details about our US benefits at this link.

Location: CA-San Diego, US Contract Type: Regular Full-Time Area: TECHNICAL Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. Grifols Diagnostic Solutions in San Diego, CA is seeking a Regulatory Affairs Specialist III. The Regulatory Affairs Specialist III is responsible for ensuring regulatory compliance and supporting global market access for in vitro diagnostic (IVD) products. It involves developing and executing regulatory strategies, preparing and submitting complex pre-market and post-market applications to FDA, EU Notified Bodies, and other international authorities, and managing communications with health agencies. This role requires collaboration with cross-functional teams, providing regulatory input throughout the product lifecycle, mentoring junior colleagues, and proactively monitoring evolving regulations to identify risks and implement mitigation plans. Strong technical expertise, analytical skills, and the ability to influence stakeholders are essential for success in this position. To qualify for the Regulatory Affairs Specialist III role, candidates must have a Bachelor's degree in life sciences, engineering, or a related field, along with at least 6 years of experience in a regulated environment, including 4 years of direct experience in Regulatory Affairs. Prior experience in the IVD or Drug/Biologics industry is required. Primary responsibilities for role: • Prepares and files complex pre-market and post-market regulatory submissions with the US FDA, Notified Bodies in the EU and other international regulatory bodies, as applicable., • Prepares clear, complete, and accurate documents that are logically constructed and comprehensive in content according to established templates and timelines., • Tracks submissions, correspondence, and commitments with health authorities and prepares responses and comments from regulatory agencies independently, proactively, in compliance with regulatory guidelines/requirements and according to established timelines., • Communicates with Health Authorities and has a demonstrated ability to facilitate requests and anticipate appropriate next steps., • Develop and execute submission strategies based on ability to understand complex technical information, and provide guidance to existing and new cross-functional product core teams for new product development and various on-market enhancements/changes from product concept to placing on the market., • Monitor progress on key project deliverables and provide status updates to management on a regular basis., • Collaborate with subject matter experts to ensure regulatory submissions requirements are being met and technical and scientific data are incorporated into regulatory submissions, and collaborate with partners and local liaisons for management of submissions in foreign countries and facilitate meetings with SMEs as needed to track progress., • Execute projects without supervision to align with and achieve the goals and timelines set by management., • Makes decisions and influences stakeholders and teammates based on gained regulatory knowledge and experience, technical expertise and current regulatory compliance trends., • Communicates moderately complex to complex regulatory topics to cross functional management, modify their communication style to fit the audience by embracing cultural differences and recognizing different knowledge levels., • Proactively research applicable regulations and guidance to the company's products and stay up to date on the current regulatory requirements and industry trends., • Assess the impact of applicable regulations to the company's products and be able to identify mitigation plans, lead mitigation projects, and make decisions that will assist in reducing regulatory risk., • Review, provide regulatory input to, and approve various quality management system related documents including utilizing scientific concepts to critically review complex reports, validations, etc. to ensure regulatory requirements are being adequately addressed., • Provide support to lower level regulatory team members by sharing gained regulatory expertise, mentoring, reviewing submissions and/or training to company products and processes., • Assess changes to product for regulatory impact and include regulatory assessments in the established change control systems, as applicable., • Prepare regulatory documentation to support regulatory inspections/audits and to meet auditor/inspector requests., • Identify process improvement initiatives and drives their successful execution., • Provides regular status updates on projects to management., • Additional duties assigned as needed. Knowledge, Skills, and Abilities • This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting., • Demonstrated ability to independently coordinate and manage complex projects, prioritize multiple responsibilities and drive projects to completion., • Demonstrated ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team., • Demonstrated interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships., • Demonstrated ability to identify issues, understand their urgency, escalate to management, and provide solutions., • Demonstrated understanding of IVD regulations, advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices., • Strong oral and written communication and presentation skills, capable of presenting and explaining complicated concepts to colleagues within the organization., • Strong technical writing skills with ability to translate scientific information into technical documentation for submission to regulatory authorities., • Demonstrates expert attention to detail with ability to identify areas of improvement and possible inconsistencies in documentation., • Expert analytical and problem-solving skills, capable of identifying problems, determining root cause and providing solutions to management., • Demonstrated ability to communicate with FDA and international customers (e.g., regulatory agencies, business partners, etc.), • Exceptional computer skills in Microsoft Office, Adobe, Excel., • Knowledge in document management control systems (e.g. LSQM), change control systems (e.g. SAP), JIRA, required. Education • Bachelor's Degree required in the life sciences, engineering or similarly related field. Experience • 6 years of experience in a regulated environment with 4 years direct experience in Regulatory Affairs. IVD or Drug/Biologics Industry experience required. Pay Scale The estimated pay scale for the Regulatory Affairs Specialist III role based in San Diego, CA, is $105,800 to $132,250 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression.

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. The Sr. Regulatory Affairs Specialist will work within Regulatory Affairs and with cross functional teams to lead RA efforts for Dexcom's software products. The Sr. Regulatory Affairs Specialist will be responsible for supporting product classifications, change assessments, registration and approval for software products, including mobile applications, AI/ML enabled data products, cloud-based solutions and cybersecurity initiatives. The Sr. Regulatory Affairs Specialist will work with marketing, software, algorithm development R&D, and quality assurance teams to help streamline internal processes in compliance to applicable FDA guidance documents and international standards. You are the RA representative on core functional teams for global software regulatory classification, change management, and regulatory submissions including: • US 510(k), pre-submissions, LTF, MDDS change assessment, • CE-marked products under EU MDR: change notifications, technical file update and submissions, MDSS notifications and in-country registrations, • ROW: work with regulatory bodies or in-country representatives for device classification, change assessment, registration and amendments, • You will work closely with SW development, engineering, architect, quality and cybersecurity teams to develop and implement streamlined software development processes and documentation to meet regulatory, quality system and compliance requirements, • You are responsible for advising on and representing RA in the assessment of global cybersecurity and data privacy initiatives, regulatory standards, requirements and guidance from regulatory authorities to meet security process and documentation requirements for global submissions. What makes you successful: • Your experience in SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO-14971, ISO-80001, IEC 62304 IEC 82304) to effectively advise on regulatory strategy, • You have excellent writing skills in regulatory documentation, including classification memos, change assessment/notifications, technical dossier and submissions. You have experience interacting with regulators., • You are passionate about digital health products in a regulated environment, strong understanding or mobile/web development, AI/ML technologies, analytics and working knowledge of agile software development methodologies., • You have effective verbal and written communication skills What you'll get: • A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community., • A full and comprehensive benefits program., • Growth opportunities on a global scale., • Access to career development through in-house learning programs and/or qualified tuition reimbursement., • An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: • 5-15% Experience and Education Requirements: • Typically requires a Bachelor's degree and a minimum of 5 8 years of related experience. Flex Workplace: • Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). Salary: $91,400.00 - $152,300.00 #DexcomUS

What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. The Sr Director, Software Quality will establish and lead Illumina's standalone Software Quality function, reporting directly to the VP of Global Quality. This leader will define the operating model, build the team, and own the end-to-end quality framework for all software products and software-driven medical devices across Illumina's global portfolio. The role requires deep technical expertise, executive presence, and the ability to work cross-functionally with R&D, Regulatory Affairs, and Commercial to ensure software quality is embedded from design through post-market surveillance. Responsibilities: • Build and lead the Software Quality function, • Establish Illumina's standalone Software Quality organization - defining structure, headcount, roles, and operating model, • Recruit, develop, and retain a high-performing team of software quality engineers with depth in IEC 62304, SaMD risk management, and cybersecurity, • Serve as the primary quality authority for all software products, software-driven IVDs, and AI/ML-enabled diagnostic tools across the global portfolio, • Own the regulatory and compliance framework for software, • Define and own Illumina's global Software Quality Management System (SQMS) in alignment with IEC 62304, ISO 14971, ISO 13485, and QMSR (21 CFR Part 820), • Lead the implementation and ongoing compliance of the EU AI Act quality and risk management requirements for AI/ML-enabled products, • Ensure all software products are correctly classified under SaMD frameworks (IMDRF, FDA Software Guidance) and that quality requirements are appropriately applied, • Drive IEC 81001-5-1 and cybersecurity-in-the-QMS implementation and maintenance activities, • Embed software quality into the product development lifecycle, • Partner with R&D to integrate software quality checkpoints into the Product Development Process (PDP): stage gates, design reviews, and risk assessments Own software-specific DFMEA, hazard analysis, and software risk management file requirements across IVD and RUO product lines, • Define and enforce software verification and validation (V&V) standards across all development teams, • Collaborate with Design Quality to maintain clear delineation between hardware and software quality responsibilities within the PDP, • Lead post-market software quality oversight, • Establish software-specific post-market surveillance (PMS) processes, including software update monitoring, cybersecurity vulnerability tracking, and SOUP (Software of Unknown Provenance) management, • Own the software CAPA process in collaboration with the Global Quality Ops team, ensuring software-origin findings are root-caused and resolved with appropriate rigor, • Manage software-related complaint investigations and MDR/vigilance reporting obligations in partnership with the Complaints and PMS function, • Operate as a senior quality leader, • Serve as the subject matter expert for software quality in regulatory inspections (FDA, BSI, MDSAP, KFDA, PMDA, NMPA) and respond to observations requiring software quality remediation, • Represent Software Quality on the monthly Quality Council and contribute to the quarterly Executive Quality Council, • Build strong working relationships with VP-level leaders across R&D, Regulatory Affairs, Commercial, and Operations, • Stay ahead of the regulatory landscape: EU AI Act implementation timelines, IMDRF SaMD updates, FDA cybersecurity guidance, and translate changes into proactive QMS updates Requirements: • Technical expertise, • IEC 62304: Deep, hands-on expertise in software lifecycle processes, not just awareness, but the ability to define, implement, and audit compliance, • SaMD classification and risk management: Demonstrated experience with IMDRF, FDA, and EU MDR/IVDR frameworks, • EU AI Act Working knowledge of requirements as they apply to medical device AI/ML software, including risk classification, technical documentation, and transparency obligations. Proficiency in cybersecurity within the QMS context: IEC 81001-5-1, TIR 57, TIR 97, and SOUP management, • ISO 14971 Strong foundation in risk management as applied to software, and ISO 13485 quality system requirements. Familiarity with software V&V methodologies, unit testing frameworks, software configuration management, and CI/CD quality integration, • Leadership and organizational experience, • Proven track record building and leading software quality teams in a regulated medical device or IVD environment, • Experience operating at the Sr Director level with direct accountability to senior quality or regulatory leadership, • Demonstrated ability to influence cross-functional stakeholders, including: engineering, product management, and regulatory, without direct authority, • Track record of building quality systems from the ground up, not just inheriting and maintaining existing ones, • Strong executive presence with the ability to communicate complex software risk clearly to non-technical leadership, • Inspection and audit readiness, • Experience representing software quality in FDA, BSI, MDSAP, or equivalent international regulatory inspections, • Comfortable owning software-related observations and CAPA responses, including interaction with regulatory bodies Experience/Education: • Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical discipline required; advanced degree preferred, • 20+ years of experience in software quality, software engineering, or a closely related function in the medical device or IVD industry, • 10+ years of leadership experience managing software quality teams or programs, • Experience in both NPI (new product introduction) and on-market sustaining software quality preferred, • Certifications desirable: CSQE (Certified Software Quality Engineer), CSSLP (Certified Secure Software Lifecycle Professional), or equivalent The estimated base salary range for the Sr. Director Software Quality role based in the United States of America is: $205,100 - $307,700. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long?term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off. We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeo

POSITION OVERVIEW The position advertised has been exempted from the federal civilian hiring freeze. Job Title SPECIAL AGENT, GL-10 Full Performance Level GS-13 Location U.S. Locations Working Hours Minimum of 50 hours per week Job Type Full Time/Permanent Who May Apply Open to ALL U.S. Citizens Salary $103,236 - $133,200 per year (calculation is base + locality + availability pay) As an FBI Special Agent, you will have the opportunity to channel your expertise to protect our nation from cyberattacks, terrorism, fraud, and evolving threats. From conducting high-stakes investigations to leveraging your in-depth knowledge to uncover crucial information, your skills are essential to investigating crimes that threaten public safety. Your transition from a specialized career to a special agent role will be transformative, utilizing your expertise to tackle national security challenges in innovative ways. MAJOR DUTIES • Plan and conduct investigations of potential violations of federal laws., • Exercise judgement, resourcefulness, and versatility in meeting investigative demands., • Create and maintain effective liaison relationships with federal, state, local, tribal, territorial and international law enforcement agencies., • Coordinate and/or participate in searches, seizures, and arrests., • Carry a firearm and be willing to use force, to include deadly force, if necessary., • Maintain a level of physical fitness to ensure readiness required to perform law enforcement duties. All applicants will be rated on the following Competencies: • Collaboration, • Communication, • Flexibility/Adaptability, • Initiative, • Interpersonal Ability, • Leadership, • Organizing and Planning, • Problem Solving and Judgment QUALIFICATIONS AND EVALUATIONS All applicants must have two years of full-time work experience and a bachelor's degree or one year of full-time work experience if you have an advanced degree (master's or doctorate degree) All applicants should demonstrate Specialized Experience (SE). SE is defined as: • Gathering and analyzing information and data to make proper conclusions or decisions., • Establishing solutions to problems, assessing vulnerabilities, considering risks, and choosing the best outcome., • Organizing, planning, and prioritizing various and competing work assignments., • Consistently navigating complex and/or evolving environments., • Communicating orally and in writing to prepare and present reports, briefings, and/or exchange information. REQUIRED DOCUMENTATION Please review the list of required documents below and submit them with your application. Your resume and supporting documentation will be used to determine whether you meet the qualifications outlined in the job announcement and to validate your responses to the online assessment questionnaire. If applying online is a hardship, please email before the closing date for assistance. If you do not submit all required documents, your application will not be processed and will be discontinued. • Utilizing the Resume Builder, outline your relevant work experience and associated start and end dates. Uploaded resumes will not be reviewed or used for qualification purposes., • Official or unofficial college transcript(s) that list your degree and the date conferred from a U.S. accredited college or university., • Former civilian Federal employees must submit a copy of your MOST RECENT SF-50 (Notification of Personnel Action) showing your tenure, grade and step, salary, and type of position occupied (i.e., Excepted or Competitive); or similar Notification of Personnel Action documentation, i.e., Transcript of Service, Form 1150, etc. This is a requirement to verify your Time in Grade (TIG). Actions such as promotion, within grade increase, or reassignment actions must be submitted as your most recent SF-50., • Memorandum for Record: (if applicable) Work performed outside assigned duties (that would not normally be documented on an SF-50, i.e., back-up duties), has to be documented in detail by an immediate supervisor in order to receive full credit for amount of time worked in that position. If no documentation is furnished, no credit will be given for time worked in that position. The following notations must be specified in the documentation (Memorandum for Record): Percent of time worked in the position (cannot conflict with main duties) The month/year work began and ended Frequency worked (i.e., daily, monthly, etc.) Specific duties performed, • Attach the Memorandum for Record to your application as type "Other" in the My Career Tools section on the Careers Home page. Current or Former Members of the Armed Forces DD-214, Member 4 copy or Service 2 copy Statement of Service (if not yet separated) VA letter dated within one year (to include Disabled Veterans) SF-15, Veterans' Preference form (optional), • Please Note: DO NOT attach a cover letter. Please make sure that all pages are readable when scanning and uploading your documents(s). DO NOT upload any picture files (JPEG, TIFF, PNG, BMP). SPECIAL AGENT APPLICATION PROCESS The application process includes the following steps, each of which must be successfully completed. Applicants who meet the initial screening criteria will receive an email invitation to take the Phase I exam. Step 1: Application and Screening Step 2: Phase I Test Step 3: Information Session Step 4: Official Physical Fitness Test (PFT) / Phase II (a) Written Step 5: Phase II (b) Interview Step 6: Conditional Appointment Offer Step 7: Background Investigation Step 8: Fit for Duty Medical Review Step 9: Basic Field Training Course Finish: Career Placement ADDITIONAL INFORMATION Opportunity to 'opt in' to returning to applicant's processing field office after accepting Final Job Offer You are strongly encouraged to review the guide before beginning the application process. This guide provides helpful information about the application and selection for the Special Agent position. Probationary employees are typically precluded from being considered for all job opportunities until 12-months of their 24-month probationary period has concluded. Veterans' preference may be subject to a one-year probationary period. Upon successful completion of the two-year probationary period, Special Agents will transition from the GL to the General Schedule (GS) pay scale. All FBI positions are in the excepted service. Positions with fitness-for-duty requirements or those requiring international travel may require proof of certain vaccinations. Failure to provide the required and relevant information as outlined in this vacancy announcement may disqualify you from consideration. Additional information will not be requested if your application is incomplete and will be evaluated solely on the information you provide. The identification of promotion potential in this announcement is not a guarantee of promotion. Advancement will depend on administrative approval, operational needs, and performance of higher-level duties. Veterans' Preference If you are entitled to veterans' preference, you should indicate the type of veterans' preference you are claiming on your resume and application. Your veterans' preference entitlement will be verified by the employing agency. Nepotism Nepotism is the act of favoring relatives in the hiring process and is prohibited by law. Public officials are prohibited from hiring or promoting relatives or relatives of officials in their chain of command, as well as actively or indirectly endorsing a relative's appointment or promotion. During the hiring process, all selected candidates and FBI hiring managers will be required to certify they are not related to anyone involved in the hiring process. Reasonable Accommodation Request The FBI provides reasonable accommodations to qualified applicants with disabilities. If you require a reasonable accommodation during the application and/or hiring process, please contact the Office of Equal Employment Opportunity Affairs (OEEOA) Reasonable Accommodation (RA) Program by email at, phone at 202-324-2158, or fax at 202-324-3976. This email address is for reasonable accommodation requests only. Do not send applications or unrelated inquiries to this address, as they will not be considered. Equal Employment Opportunity The FBI is an Equal Opportunity Employer, and all qualified applicants will receive consideration for this vacancy. Unless explicitly authorized by law, selection will be made without regard to, and there will be no discrimination because of, color, race, religion, national origin, marital status, parental status, physical or mental disability, genetic information, age (40 or over), sex, pregnancy and related conditions, or on the basis of personal favoritism, or any other non-merit factors. Benefits The Bureau matches your dedication with a commitment to professional growth, a supportive work environment, and a robust benefits package that prioritizes you. As a member of our team, you'll enjoy comprehensive health and life insurance benefits, paid vacation, sick leave, and federal holidays. For more details about benefits available to all federal employees, visit the Office of Personnel Management's.

Will be a key member of the GRSP Extended Leadership Team to ensure the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area. Acts as regulatory representative on various company-wide projects and initiatives. Support due diligence and business development assessments. Working with regional regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned development assets and marketed products: Develop global therapeutic regulatory strategies and operational plans for identified investigational and marketed products. Review/provide counsel on product development plans. Assemble the global regulatory plans for identified projects/products. Influences and imparts broad expertise regarding US and international regulatory environment. Provides strategic and operational advice to the development and commercialization teams, serving as the primary global point person for assigned projects. Evaluates emerging regulations and changing regulatory landscape for impact and provides strategic advice for assigned projects. Serve as the primary interface with health authorities on assigned projects. Identifies issues or is assigned projects that will impact BMS, regulatory affairs or projects and provides strategies for dealing with them. Works with the regulatory product managers (submissions) and regulatory operations group, for preparation, production and submission of health authority documents using internal & external resources. Works with regional international staff for diverse health authority submissions. Skills / Requirements Advanced degree in scientific discipline; MD, PhD or PharmD preferred, experience in neurology, neuromuscular diseases or neuropsychiatry drug development strongly preferred. 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs. Global experience strongly preferred with command of US experience and EU background desired. Thorough knowledge of the drug research, development, and commercialization process. Demonstrated specific expert in one or more key areas Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional. Inter-dependent partnering skills, team-oriented and ability to influence outcomes necessary. Sensitivity and experience with non-domestic organizations/cross-cultural environments. Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously. Must be able to innovate, analyze and solve critical/complex business problems. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Cambridge Crossing: $258,680 - $313,460 Princeton - NJ - US: $226,750 - $274,763 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

Job Description About Synchron Synchron’s vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Senior Quality Engineer (New Product Development) Quality Location: San Diego, CA (On-site) Employment Type: Full-Time About the Role As Senior Quality Engineer (New Product Development), you will serve as the Quality lead across Synchron’s product development programs, partnering with R&D, Systems Engineering, Clinical, Regulatory Affairs, Manufacturing Engineering, and Operations to ensure quality is built into products from concept through commercialization. You will lead Design Quality activities, ensure compliance with FDA, ISO 13485, ISO 14971, and applicable international regulations, and facilitate successful transfer of new products into manufacturing. You will also provide operational quality support during pilot builds and early production while contributing to the development and continuous improvement of Synchron’s Quality Management System. Key Responsibilities Design Quality & New Product Development • Serve as the Quality representative on cross-functional product development teams from concept through commercialization., • Ensure compliance with Design Controls in accordance with FDA 21 CFR Part 820, ISO 13485, and applicable global regulations., • Lead Design Quality deliverables including:, • Design Reviews, • Design Verification & Validation (V&V), • Design History File (DHF) development, • Traceability, • Engineering Change Assessments, • Facilitate product risk management activities in accordance with ISO 14971, including hazard analyses, risk assessments, FMEAs, and verification of risk controls., • Review and approve product requirements, specifications, protocols, reports, drawings, and engineering documentation to ensure quality and regulatory compliance., • Collaborate with engineering teams to establish critical quality attributes, acceptance criteria, and design inputs/outputs., • Drive Design for Manufacturability (DFM), Design for Assembly (DFA), Design for Reliability (DFR), and Design for Quality (DFQ) principles throughout development., • Up to 20% travel expected, primarily for contract manufacturer visits and supplier audits.Design Transfer & Manufacturing Readiness, • Partner with R&D and Manufacturing Engineering to execute successful design transfer into production., • Develop manufacturing quality strategies including Process FMEAs, Control Plans, inspection strategies, and manufacturing quality gates., • Support process validation activities (IQ/OQ/PQ), equipment qualification, and pilot manufacturing builds., • Evaluate manufacturing readiness and identify quality risks prior to product launch., • Support engineering changes through impact assessments and change control activities.Operations & Supplier Quality, • Collaborate with Operations and Supplier Quality to qualify suppliers and contract manufacturers supporting new product development., • Review supplier validation activities, incoming inspection strategies, and quality documentation., • Support investigations involving nonconforming materials, manufacturing deviations, and CAPAs associated with prototype and pilot production., • Monitor quality metrics during new product introduction (NPI) and drive continuous improvement initiatives.Quality Systems & Regulatory Support, • Author and maintain Design Quality documentation including:, • Design Plans, • DHFs, • Risk Management Files, • SOPs, • Quality Plans, • Verification & Validation protocols and reports, • Support Regulatory Affairs during submissions by ensuring quality documentation is complete and inspection-ready., • Participate in internal audits, supplier audits, FDA inspections, and Notified Body audits., • Contribute to continuous improvement of Synchron’s Quality Management System. Required Qualifications • Bachelor’s degree in mechanical engineering, Biomedical Engineering, Electrical Engineering, or a related technical/science field, • 7+ years of Quality Engineering experience in an FDA-regulated medical device environment with demonstrated experience supporting new product development, design controls, risk management, verification & validation, and design transfer., • Experience supporting Class III medical devices preferred. CERTIFICATIONS Preferred Qualifications • ISO 13485:2016 Lead Auditor Certification (or willingness to obtain); CQE or CQA preferred., • Demonstrated knowledge of FDA Design Controls and product development processes., • Strong understanding of ISO 13485, ISO 14971, FDA 21 CFR Part 820, and applicable product standards., • Experience with Design Verification, Validation, Design Reviews, Design History Files, and traceability., • Experience performing Design and Process FMEAs and applying risk management principles., • Knowledge of process validation (IQ/OQ/PQ), manufacturing process development, and design transfer., • Familiarity with supplier quality management and contract manufacturing., • Ability to interpret engineering drawings, GD&T, and product specifications., • Strong technical writing and documentation skills., • Excellent communication and collaboration skills within multidisciplinary development teams., • Ability to balance innovation with regulatory compliance in a fast-paced product development environment. Compensation The base salary range for this role is $130,000 – $150,000 depending on experience, skills, and qualifications. In addition to base salary, this role may be eligible for discretionary bonuses and/or equity grants, subject to board approval and company policy. Visa Sponsorship We are unable to offer visa sponsorship for this position currently. Benefits (for W-2, full-time, exempt employees in the US only) *Intern positions not eligible • Subsidized medical and dental insurance coverage for you and your dependent(s), • Life insurance, short-term disability, long-term disability, • 401k, • Discretionary unlimited PTO, • Flexible Spending Account for you and your dependent(s), with eligible plan elections, • Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission, and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply now and build the future with us.

Job DescriptionDescription: Company Description Davenergy Solutions is a rapidly growing, profitable company headquartered in San Diego, CA. Our employees are the key to maintaining our competitive edge. To attract and retain the best industry talent, Davenergy Solutions shares its success with its employees and is committed to providing a professional work environment where learning, growth, and recognition are highly valued. If you are seeking an opportunity to work in a progressive organization that offers diversified challenges and excellent opportunities for advancement, we encourage you to review our current employment opportunities. For more information about Davenergy Solutions and open positions, please visit www.davenergy.com. Position Summary We are seeking a qualified Fire Protection Engineer (FPE) to support healthcare and federal facility projects for the U.S. Department of Veterans Affairs (VA) and the Department of Defense (DoD). This position is responsible for performing comprehensive fire protection and life safety (FLS) design reviews, peer reviews, and field inspections to ensure compliance with applicable federal standards, VA Technical Information Library (TIL) requirements, Unified Facilities Criteria (UFC), NFPA codes, and local life safety regulations. What You'll Do As a Fire Protection Engineer, you'll play a critical role in protecting patients, healthcare staff, and federal facilities by ensuring fire protection and life safety systems meet the highest standards of engineering excellence. Through independent technical reviews, multidisciplinary coordination, field inspections, and final compliance certifications, you'll help deliver safe, code-compliant healthcare environments for the Department of Veterans Affairs and the Department of Defense. Working closely with multidisciplinary engineering teams, you will ensure fire protection systems are effectively integrated into mechanical, electrical, plumbing (MEP), and architectural designs for complex healthcare facilities while supporting the VA throughout the design review process. Requirements: Key Responsibilities Fire Protection & Life Safety Design Reviews • Perform independent peer reviews of fire protection and life safety (FLS) design documents prepared and sealed by outside engineering firms., • Review fire protection drawings and specifications for compliance with:, • VA Technical Information Library (TIL), • Unified Facilities Criteria (UFC), • NFPA Codes and Standards, • International Building Code (IBC), • International Fire Code (IFC), • Local Authority Having Jurisdiction (AHJ) requirements, • Review stand-alone life safety upgrade designs to verify compliance with applicable VA and DoD requirements., • Ensure fire protection systems can be effectively incorporated into hospital designs alongside mechanical, electrical, plumbing, and architectural systems., • Review sprinkler system evaluations and fire distribution reports to ensure they meet Government (GVT) intent and Statements of Work (SOW) developed by the VA. VA Design Review Process • Perform formal Fire Protection and Life Safety (FLS) reviews following receipt of design review requests and associated project documentation submitted by the VA's designated representative., • Review a variety of design documents, including:, • Design narratives, • Technical specifications, • Construction drawings, • Engineering calculations, • Requests for Information (RFIs), • Other design documentation in accordance with VA Program Guide PG-18-15 and applicable A/E submittal requirements., • Conduct review milestones throughout the design process, including intermediate and final design submissions., • Perform a comprehensive backcheck of all 65% design review comments against the 100% design submission to verify all comments have been adequately addressed., • Complete a final design review confirming compliance with all applicable codes, standards, VA criteria, and project requirements., • Prepare and issue a final certification letter stating the completed design complies with the latest applicable codes, standards, VA TIL requirements, and Unified Facilities Criteria (UFC). Field Inspections & Technical Support • Conduct on-site inspections of fire protection and life safety systems during construction or post-installation., • Verify installed systems conform to approved design documents and project specifications., • Document findings and prepare detailed inspection reports for submission to the VA., • Identify design deficiencies, code conflicts, and constructability issues while providing practical recommendations for resolution., • Participate in technical meetings with project teams, clients, architects, engineers, and government representatives. Required Qualifications • Bachelor's degree in Fire Protection Engineering or a closely related engineering discipline., • Professional Engineer (PE) license in Fire Protection Engineering or another engineering discipline with significant fire protection experience., • U.S. Citizenship is required., • Minimum 5 years of fire protection engineering experience, preferably supporting federal healthcare or government facilities., • Demonstrated experience performing fire protection and life safety design reviews., • Strong knowledge of:, • VA Technical Information Library (TIL), • Unified Facilities Criteria (UFC), • VA Program Guide PG-18-15, • NFPA Codes and Standards, • NFPA 101 Life Safety Code, • International Building Code (IBC), • International Fire Code (IFC), • Experience interpreting engineering drawings, specifications, calculations, and technical reports., • Excellent written communication skills with experience preparing formal technical review comments and compliance documentation., • Ability to travel to project sites as required. Preferred Qualifications • Experience supporting Department of Veterans Affairs (VA) projects., • Experience supporting Department of Defense (DoD) projects., • Healthcare facility engineering or hospital design experience., • Experience performing independent design reviews for government clients., • Familiarity with federal design review and quality assurance processes., • NICET certifications or additional fire protection credentials are a plus., • Active security clearance or ability to obtain one is preferred. Benefits • 401(k), • Bi-Weekly 401(k) Company Contribution (3% of Salary), • Annual Profit-Sharing contribution to 401(k), • 10 Paid Federal Holidays, • Health Insurance, • Dental Insurance, • Vision Insurance, • Paid Time Off Optional Benefits • Accident Coverage, • Short Term Disability, • Term Life Insurance, • Medical Bridge, • Critical Illness Any and all job offers are contingent pending work status eligibility and passing a federal government background check.

At Marriott International, we are dedicated to being an equal opportunity employer, welcoming all and providing access to opportunity. Marriott International considers for employment qualified applicants with criminal histories consistent with applicable federal, state and local law.

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