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Job Description Help Us Build the Future of the Human Heart. At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients another shot at life. If that's the kind of work that gets you out of bed in the morning, we think you belong here. About the Role The Cleanroom Packaging Technician is a hands-on role responsible for the packaging, labeling, and preparation of Class III medical devices for sterilization and distribution in compliance with documented procedures, quality standards, and regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 11607). This role requires precision, a quality-first mindset, and strict adherence to cleanroom protocols. This hands-on role contributes to the advancement of BiVACOR's innovative cardiovascular technology, requiring attention to detail and a commitment to patient safety. Key Responsibilities Package, label, and inspect finished medical device components and assemblies in accordance with approved work instructions and SOPs Maintain sterile barrier integrity throughout the packaging process in compliance with ISO 11607 Complete production records, batch documentation, and device history records (DHRs) accurately and in real time Perform in-process quality inspections and communicate any non-conformances or quality concerns promptly Dispose of hazardous and controlled waste materials in designated areas per facility protocols Maintain cleanroom compliance including gowning, housekeeping, and environmental monitoring requirements Support packaging process validations, qualifications, and continuous improvement initiatives Maintain training proficiency and certifications to remain in compliance with GMP and GDP requirements Collaborate with Manufacturing, Quality, and Engineering teams to support daily production goals What You Bring High school diploma or equivalent required; Associate's degree or technical certification preferred Minimum 1–2 years of experience in a cleanroom or regulated manufacturing environment, preferably medical devices or pharmaceuticals Familiarity with FDA 21 CFR Part 820, ISO 13485, and GMP/GDP requirements Strong attention to detail and ability to follow written procedures precisely Fine motor skills required for handling delicate components and packaging materials Ability to read and accurately complete batch records and production documentation Strong verbal and written communication skills Physical Requirements Ability to sit and/or stand for extended periods of time as needed Capability to lift and move up to 25 lbs when needed Willingness to wear full cleanroom attire (gown, gloves, mask, bouffant, etc.) for entire shifts Ability to work overtime as required What We Offer BiVACOR offers a competitive compensation package and comprehensive benefits, including: 401(k) with company matching Medical, dental, and vision insurance Health Savings Account (HSA) & Flexible Spending Account (FSA) Life insurance & Employee Assistance Program Generous paid time off The expected salary range for this position based in Huntington Beach California is $22.00 to $28.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting Apply today and be part of something extraordinary. BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Oncology Clinical Research Coordinator - Fountain Valley, CA Location: Fountain Valley, CA Schedule: Monday-Friday Pay: $33.65 - $42/hour The Clinical Research Coordinator works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Additional duties and responsibilities: • Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process., • Scheduling of patients for research visits and procedures., • In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following: changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug., • Maintains accurate source documents related to all research procedures., • Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries., • Schedules and participates in monitoring and auditing activities., • Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings., • Notifies direct supervisor about concerns regarding data quality and study conduct., • Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines., • May involve in assisting with patient research billing and reconciliation., • Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board., • Maintains research practices using Good Clinical Practice (GCP) guidelines., • Maintains strict patient confidentiality according to HIPAA regulations and applicable law., • May coordinate training and education of other personnel., • May participate in centralized activities such as auditing, Standard Operating Procedure development, etc. Requirements: • 2+ years of experience working as a Clinical Research Coordinator, • Bachelor's degree in a related discipline, • Bilingual in Spanish is a plus, • Oncology trial experience

Title: Clinical Research Coordinator I Location: Fountain Valley/Long Beach Department: Research Admin Status: Full Time Shift: Days Pay Range*: $37.27/hr - $54.01/hr At MemorialCare Health System, we believe in providing extraordinary healthcare to our communities and an exceptional working environment for our employees. Memorial Care stands for excellence in Healthcare.Across our family of medical centers, we support each one of our bright, talented employees in reaching the highest levels of professional development, contribution, collaboration and accountability.Whatever your role and whatever expertise you bring, we are dedicated to helping you achieve your full potential in an environment of respect, innovation and teamwork. Position Summary The Clinical Research Coordinator fulfills the requirements of recruiting, enrolling and conducting follow-up of study participants in clinical trials related to all therapeutic areas represented throughout MemorialCare. In doing so, the Clinical Research Coordinator I is responsible for coordinating trial participation of study volunteers with the trial's protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.). The Clinical Research Coordinator I is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol. After hours support and coverage may be needed to adequately meet the needs of the research subject and/or adhere to the protocol recruitments. After-hours Support Staff will be compensated for his/her time providing support during these after hours. Essential Functions and Responsibilities of the Job • Under direct supervision of the Director of Clinical Operations, Manager of Clinical Operations and principal investigator, the CRC 1 is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants in clinical trials., • Collaborates with study investigator in determining eligibility of potential participants in clinical trials., • Screens potential participants for protocol eligibility. Presents trial concepts and details to the participant, participates in the informed consent process, and enrolls participants in study protocol., • Ensures research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations., • Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide participants' education regarding medication administration. Maintains investigational drug accountability, when needed, in cases where the Research Pharmacy is not maintaining that responsibility., • In collaboration with the study investigator, reviews study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings., • Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities., • Maintains current and accurate documentation in the regulatory binder(s) as required by regulations and sponsors., • Participates in required training and education programs. Responsible for education of other personnel and vendors regarding clinical research., • Provide a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards. Maintains strict patient confidentiality according to HIPAA regulations and applicable law., • Participates in the after-hours support and coverage schedule, if necessary. Be at work and be on time. Interact in a positive and constructive manner. Follow company policies, procedures and directives. *Placement in the pay range is based on multiple factors including, but not limited to, relevant years of experience and qualifications. In addition to base pay, there may be additional compensation available for this role, including but not limited to, shift differentials, extra shift incentives, and bonus opportunities. Health and wellness is our passion at MemorialCare-that includes taking good care of employees and their dependents. We offer high quality health insurance plan options, so you can select the best choice for your family. And there's more...Check out our_for more information about our Benefits and Rewards.

Job Locations US-CA-Huntington Beach ID 2026-19337 Element has an opportunity for a LIMS Support Specialist to join our growing Lab Systems Support team. This role is critical in ensuring the stability, performance, and user experience of Laboratory Information Management Systems (LIMS) across the Americas (U.S., Canada, and Mexico). Reporting to the Head of Lab Systems Support, you will provide first- and second-line technical support across a diverse portfolio of LIMS platforms, including SaaS, custom-built, and hybrid solutions. You'll partner closely with global teams, laboratory stakeholders, and IT to resolve issues, enhance system functionality, and drive continuous improvement. Hybrid Position: 3 days a week onsite in Huntington Beach, CA and 2 days remote Salary range: $80,000 to $100,000 annually (Depending on Experience) Please note: Sponsorship is not available for this opportunity. Serve as the primary point of contact for LIMS-related support across the Americas region • Triage, prioritize, and resolve incidents and service requests in alignment with SLA targets, • Troubleshoot software, hardware, and network issues impacting LIMS performance, • Support end users with system navigation, functionality, and issue resolution, • Perform system configurations, updates, and enhancements to meet business needs, • Collaborate with global support teams to ensure consistent service delivery and knowledge sharing, • Develop and maintain documentation including user guides, SOPs, and knowledge base articles, • Support testing, validation, and deployment of system upgrades, patches, and new features, • Identify recurring issues and recommend long-term solutions to improve system stability and usability, • Partner with laboratory and IT stakeholders to support integrations, customizations, and process improvements, • Bachelor's degree in Information Technology, Computer Science, Engineering, or related field (or equivalent experience), • Experience supporting enterprise systems (SaaS, custom, or hybrid), ideally within a laboratory or scientific environment, • Strong troubleshooting skills across software, hardware, and network environments, • Working knowledge of:, • Programming languages such as .NET, Python, VBA, or Java, • SQL databases (querying, troubleshooting, basic optimization), • Microsoft Power Platform (Power Automate, Power BI), • Excellent communication skills with the ability to support technical and non-technical stakeholders, • Strong analytical mindset with attention to detail and problem-solving capability, • Ability to work independently and collaboratively in a global, cross-functional environment, • Flexibility to adapt to changing priorities and support critical issues outside standard hours when needed Preferred: • Experience with LIMS platforms or laboratory systems, • Understanding of laboratory operations, data integrity, and regulatory standards (ISO, FDA, ITAR, Nadcap) Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to 'Make tomorrow safer than today'. When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access. While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development. Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization. At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming "the world's most trusted testing partner". All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws. The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) "If you need an accommodation filling out an application, or applying to a job, please email Recruitment@element.com"

Job Description Position Overview Document Control Specialist is responsible for maintaining organized and updated documents related to ISO compliance. Duties include using document management software to upload or scan paper documents, retrieving documents for authorized personnel and ensuring document storage to comply with laws and regulations. Coordinate and/or perform the day-to-day activities of Quality Systems such as supplier qualification, deviation management, change management and document control. Assist in assuring that TS Conductor operates in accordance with current Good Manufacturing Practices & regulations and in compliance with ISO 9001:2015 Quality standards and other ISO standards. Essential Functions • Managing the intake, handling, and storage of documents., • Developing and implementing processes for document control., • Ensuring all documentation meets formal requirements and standards., • Reviewing and updating documents as necessary., • Tracking and managing versions of documents., • Retrieving files as needed by company staff., • Securing backup and storage of documents., • Ensuring all documentation is discoverable and accessible, • Collaborate with various departments to ensure completion of deviation investigations, CARs, change controls and NCRs, • Maintain supplier qualification program:, • Evaluation supplier self-audit questionnaire, • Assist audit team during site quality system audits, • Tracking supplier performance, • Establishment of Quality Agreements/Clauses, • Participate in internal, external, third party and regulatory audits and provide responses as needed, • Support additional project team activities and/or investigations and participate in process improvement activities and projects., • Manage changes generated in the quality system and keep the information updated and available in the system., • Work closely with various teams to ensure that all documents are complete, accurate and up to date., • Review the status of external calibration equipment/tools that require calibration and coordinate their collection when required., • Request information on monthly results from the different departments to produce the monthly metrics report., • Keep track of the Calibration and Safety labels., • Control the communication documents with clients and/or suppliers such as corrective actions, NCR (non-conforming material report), deviations, etc., • Perform documentary control of Work instructions/Standard Operation Procedures related to the different areas of the company., • Verify that the proposed changes to procedures or records comply with the quality system standard., • Participate as a member of the internal audit team of the quality system., • Supervise and ensure compliance with document control procedures and policies., • Additional duties as assigned. Incentives Benefits offered the first of the month following 30 days of employment, include: medical, dental, life insurance, long term disability, paid time off (sick and vacation), 10 company holidays, 401(k) with company match, etc. • Referral Rewards program Requirements / Training and Experience • Work experience 1 to 5 years in Quality Departments., • Preferred Bachelor's and associate degree in Associates, Engineering, Education, Technical, Business, Management, Science, Computer Science, Manufacturing, Business/Administration, • Excellent communication skills, Attention to the details, Problem solving skills. Strong work ethic and a commitment to engineering excellence and data-driven decision making. Works well on projects on their own as well as with a team, able to clearly communicate ideas., • Preferred licenses or certifications required by the position: ISO, FDA, SQF, PO, MO, APICS, ASQ, 9001, GMO, LEAN, • Experience working with a document control system which maintains, and processes document revision as approved by change control, • Required knowledge of various digital applications, file formats and design limitations, • Must be able to organize/prioritize existing resources and incorporate new information, as needed, to implement the most effective solutions., • Able to apply excellent functional computer knowledge in utilizing Microsoft Windows, MAC, or other technical tools in completing assignments., • Requires excellent communication skills with ability to state messages in a clear manner by using language that is easy for others to understand., • Able to explain programs policies and procedures in language that is understood by others., • Requires strong understanding of the impact of a message on the organization or customer., • Experience in document control and internal audits., • Proficient computer equipment and Microsoft Office tools., • Knowledge of ISO 9001:2015., • Strong communication and interpersonal skills., • Ability to effectively communicate with internal leaders as well as suppliers and customers., • Excellent attention to detail and commitment to producing high-quality work., • Ability to work autonomously and manage several tasks at the same time., • Ability to prioritize tasks and work effectively in a fast-paced environment., • Must be able to successfully pass E-Verify background check.

Job DescriptionDescription: Medit is a global leader in 3D dental imaging and digital dentistry, with a $2B valuation and customers in over 100 countries. Our industry-leading intraoral scanners and open-platform software are transforming dental workflows worldwide. As we continue to grow across North and Latin America, we are seeking a senior-level RA/QA expert to own and lead our regional compliance strategy. The Opportunity This role covers both medical device hardware and Class II SaMD (software as a medical device). You will take full ownership of regulatory and quality operations across the U.S., Canada, and LATAM — including FDA Class II 510(k) submissions, ISO 13485 quality systems, and regulatory leadership for both physical devices and software platforms. You’ll collaborate directly with our global HQ in Korea and operate with a high degree of autonomy. What You’ll Own Regulatory Strategy & Submissions • Lead and manage Class II regulatory submissions including FDA 510(k), Health Canada, ANVISA, and LATAM filings for both hardware and software, • Serve as U.S. and LATAM regulatory liaison with global HQ and local authorities, • Monitor evolving regulations and proactively adjust strategy across jurisdictions Quality System Ownership • Ensure ongoing compliance with ISO 13485, MDSAP, and QSR requirements, • Own and maintain quality assurance systems, CAPAs, SOPs, and change control, • Support audits and inspections from FDA, Health Canada, and other regulators Cross-Functional Leadership • Work closely with R&D, product, legal, and support teams to ensure regulatory alignment, • Guide internal teams on regulatory best practices and QA processes, • Represent Medit in external conversations with regulatory bodies and partners Requirements: What We’re Looking For • 7–10+ years of experience in Regulatory Affairs and Quality Assurance, ideally with both medical devices and digital health products, • Demonstrated success leading FDA Class II 510(k) submissions, especially for SaMD, • Strong knowledge of ISO 13485, MDSAP, QSR, and related standards, • Experience operating independently in cross-border environments (U.S., Canada, LATAM), • Proven ability to make decisions and drive compliance without heavy oversight, • Excellent project management and documentation skills, • Bachelor’s degree required; advanced degree or RAC certification a plus, • English fluency required; Spanish or Portuguese is a plus

Job Description POSITION SUMMARY: The Sr. Specialist, QA Batch review is a senior-level position responsible for leading the comprehensive review of complex batch production records and associated documentation to ensure compliance with FDA, EMA, and internal QMS requirements prior to product disposition and release. Serves as a technical subject matter expert (SME) for batch record review, provides mentorship to junior specialists, drives quality system improvements, and represents QA during internal and regulatory inspections within a CDMO environment. PRINCIPAL DUTIES: Advanced Batch Record Review • Independently conduct thorough review of complex executed batch records and all associated documents (testing reports, deviations, cleaning records, equipment logs) for completeness, accuracy, clarity, and regulatory compliance., • Review and approve draft batch records prior to manufacturing to ensure clarity and compliance., • Verify critical process parameters, in-process controls, and documentation for high-risk or complex product campaigns., • Final responsibility for verifying that batch record information is complete prior to batch record release., • Apply a risk-based approach to prioritize review activities and escalate critical findings appropriately., • Ensure timely and compliant review to meet manufacturing, supply chain, and client cycle time demands., • Oversee creation and scanning of batch record package binders and ensure archival accuracy. Deviation, CAPA & Change Control • Lead or support the review, investigation, and closure of deviations impacting batch quality., • Drive CAPA development, implementation, and effectiveness checks related to systemic batch record errors., • Review and approve change control documentation affecting batch record processes., • Report nonconformances and lead escalation and resolution efforts., • Proactively identify quality risks and implement mitigation strategies or escalate as needed. Mentoring & Training • Provide technical guidance and mentorship to Associate Specialist and Specialist (L1 & L2)., • Assist in onboarding, training, and competency evaluation of junior specialists., • Foster a culture of accountability, continuous improvement, and collaboration within the team. Compliance, Audits & Inspections • Serve as SME for batch record review during internal audits and external regulatory inspections (FDA, EMA, client audits)., • Support preparation of responses to audit observations related to batch record review., • Ensure strict adherence to regulatory standards (FDA, EMA, ICH, ISO, GMP) and ALCOA+ principles. Process Optimization & Cross-Functional Collaboration • Identify systemic inefficiencies in QA workflows and lead implementation of improvements., • Partner with manufacturing, R&D, supply chain, and regulatory affairs to embed quality throughout the product lifecycle., • Assist in the development, revision, and approval of SOPs related to batch record review and product release., • Track and report KPIs related to batch record review performance to QA leadership., • May perform other duties as assigned. JOB REQUIREMENTS: • Expert-level knowledge of cGMP (US, EU, ICH) regulations and manufacturing processes (Form/Fill, Visual Inspection, Packaging, Utilities)., • Advanced proficiency in quality systems: Deviation, CAPA, Change Control, OOS/OOT, Document Control, and Material Review., • Demonstrated ability to lead complex investigations and implement effective CAPAs., • Strong risk management and decision-making skills., • Proven ability to present technical information and regulatory compliance data to senior management and regulatory agencies., • Excellent verbal, written, and organizational communication skills., • Ability to mentor and develop junior staff effectively., • Proficient in continuous improvement methodologies (e.g., PDCA, Six Sigma, Lean)., • Strong analytical and problem-solving skills with attention to detail., • Must demonstrate integrity, accountability, sound judgment, intellectual honesty, and an uncompromising commitment to quality., • Proficient in eQMS platforms and Microsoft Office Suite. EDUCATION and/or EXPERIENCE: • Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or related field required., • 5–8 years of progressive experience in batch record review and/or product release in a GMP-regulated environment., • Demonstrated experience in CDMO or pharmaceutical manufacturing operations., • Experience supporting regulatory inspections (FDA, EMA) as a subject matter expert preferred., • Strong analytical, organizational, and communication skills with a proven track record of leading quality improvements. Physical Requirements • Ability to lift and carry boxes or binders weighing up to 25 lbs., • Ability to stand, walk, and move between departments or storage areas as part of regular duties.

Job Description Help Us Build the Future of the Human Heart. At BiVACOR, we’re developing the world’s most advanced total artificial heart, a technology capable of saving millions of lives around the world. We’re a team united by purpose, working on something truly unprecedented. Every site you prepare, every milestone you track, and every compliance requirement you uphold plays a direct role in giving patients another shot at life. If that’s the kind of work that gets you out of bed in the morning, we think you belong here. About the Role This is a high-impact, cross-functional role at the heart of BiVACOR’s clinical program, where your operational expertise will directly shape the success of our first-in-human and pivotal clinical studies. As Clinical Operations Manager, you will be the organizational backbone of site-level activity, ensuring every participating center is prepared, compliant, and ready to support patients receiving the world’s first Total Artificial Heart. You will bring meticulous attention to detail, a deep understanding of clinical trial operations, and a collaborative approach that keeps complex, multi-site programs on track. Key Responsibilities Oversee day-to-day operational logistics for clinical study activities at participating sites Maintain site qualification documentation, essential regulatory binders, and operational SOPs Track site-level operational milestones and flag deviations Coordinate supply chain activities related to clinical device inventory and investigational materials Support site initiation visits and ensure operational readiness prior to patient enrolment Liaise with clinical research and regulatory affairs on site-level compliance requirements What You Bring Bachelor’s degree in Life Sciences, Health Sciences, or a related field; advanced degree or CRA/CRC certification preferred 3–5+ years of clinical operations, clinical trial management, or site management experience in a medical device or pharmaceutical environment Solid understanding of ICH-GCP, FDA IDE regulations, and essential document requirements for investigational device studies Experience managing regulatory binders, site qualification documentation, and investigational supply logistics Proficiency with clinical trial management systems (CTMS) and electronic trial master file (eTMF) platforms Can-do attitude — highly organized — strong cross-functional communication and stakeholder management skills Willingness to travel to clinical sites as required; flexibility to support BiVACOR as our program scales What We Offer BiVACOR offers a competitive compensation package and comprehensive benefits, including: 401(k) with company matching Medical, dental, and vision insurance Health Savings Account (HSA) & Flexible Spending Account (FSA) Life insurance & Employee Assistance Program Generous paid time off This role may be based at BiVACOR’s Huntington Beach headquarters. The expected salary range for this position based in Huntington Beach California is $118,000 to $154,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting. Apply today and be part of something extraordinary. BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Compensation Range: $118K - $154K

Job Description Job description:- Position Name: Clinical Research Coordinator-RN Department: Cancer Clinical Research Type: Full Time/Permanent - Direct Hire Location: Newport Beach, CA,92663 Available Shifts: M-F 8:30 – 5 pm (based on patient schedule) Pay Rate: $52-$75/hour plus benefits Overview: We are seeking a dedicated and highly organized Clinical Research Coordinator - Registered Nurse (RN) to join our dynamic research team. This pivotal role involves overseeing clinical trial activities, ensuring compliance with regulatory standards, and providing comprehensive patient care throughout the research process. The ideal candidate will possess strong nursing expertise combined with experience in clinical trials management, demonstrating a commitment to advancing medical knowledge and patient safety. This position offers an excellent opportunity to contribute to innovative clinical development projects within a collaborative environment. Duties • Coordinate and manage all aspects of clinical trials, including patient recruitment, enrollment, and follow-up procedures, ensuring adherence to protocol guidelines., • Monitor patient health status through vital signs assessment, blood sampling, and ongoing observation, documenting findings accurately within electronic medical record (EMR) systems., • Review and verify clinical documentation for completeness and compliance with FDA regulations, ICH Good Clinical Practice (GCP) standards, and CDISC data standards., • Conduct phlebotomy procedures, blood sampling, and other clinical laboratory tasks with precision and safety., • Ensure proper data collection, management, and reporting using statistical software tools; maintain meticulous records for audit readiness., • Oversee compliance with HIPAA regulations and institutional policies to safeguard patient confidentiality., • Supervise research staff and coordinate training activities related to protocol procedures, documentation review, and regulatory compliance., • Collaborate with multidisciplinary teams including physicians, laboratory personnel, and regulatory bodies to facilitate smooth trial operations., • Assist in the preparation of regulatory submissions, progress reports, and audit documentation., • Maintain knowledge of FDA regulations, ICH GCP guidelines, and clinical laboratory best practices to ensure ongoing compliance. Required Skills & Experience: -Two (2) or more years of experience performing clinical research duties or equivalent experience and training. -Excellent analytical and problem-solving skills. -Excellent verbal and written communications and presentation skills; excellent organizational skills; close attention to detail and excellent interpersonal skills to work effectively in a diverse team. -Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects. -Ability to establish cooperative working relationships with patients, co-workers, & physicians. -Behaves in a professional manner in all settings and promotes team building. -Follows policies set by the organization and department.Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines. -Understanding of clinical trial methodologies and experience filing Institutional Review Board documents. -Ability to abstract data from medical records and transfer it to data collection forms or directly into databases. -Proficiency with Microsoft Word, PowerPoint, and Windows. Preferred Skills & Experience: -Working knowledge of FDA, NIH, and OHRP regulatory requirements. -Working knowledge of ICH Good Clinical Practice guidelines. -Understanding of clinical trial methodologies. -Experience filing Institutional Review Board documentation. -Ability to abstract data from medical records and transfer information into data collection forms or electronic databases. Required Certifications & Licensure: -Current licensure in good standing as a Registered Nurse in the State of California. -Basic Life Support (BLS) Certification. Company DescriptionLanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.

Job Description Help Us Build the Future of the Human Heart. At BiVACOR, we’re developing the world’s most advanced total artificial heart, a technology capable of saving millions of lives around the world. We’re a team united by purpose, working on something truly unprecedented. Every site you activate, every team member you develop, and every data point you interpret plays a direct role in giving patients another shot at life. If that’s the kind of work that gets you out of bed in the morning, we think you belong here. About the Role This is a senior, high-impact leadership role at the center of BiVACOR’s US clinical program, where your expertise will shape how we conduct, manage, and report on one of the most groundbreaking medical device studies of our time. As Senior Clinical Research Manager, you will own end-to-end US IDE study operations, leading a team of clinical research professionals, ensuring regulatory compliance across all active sites, and driving the clinical strategy that will help bring the world’s first Total Artificial Heart to patients who need it most. You will bring deep clinical trial expertise, strong leadership instincts, and the scientific acumen to translate complex data into compelling, accurate clinical narratives. Key Responsibilities Manage all US IDE clinical study operations including site activation, enrolment, and monitoring Lead and develop a team of Clinical Research Specialists/Site Managers and Clinical Research Associates Ensure US sites maintain GCP compliance, FDA regulations, and protocol adherence Serve as the primary liaison with US IRBs, site Principal Investigators, and study coordinators Maintain the Trial Master File per ICH E6(R2) and ISO 14155:2020; prepare for and support inspections and audits Collaborate on clinical strategy and author key clinical documents including clinical study protocols, clinical study reports, clinical evaluation plans/reports, annual progress reports, risk-benefit analyses, and clinical marketing materials Develop a deep understanding of clinical data; interpret and communicate complex results in a clear, concise, and scientifically accurate manner across a wide range of audiences What You Bring Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related field; advanced degree preferred 5+ years of clinical research experience in a medical device or pharmaceutical environment, with at least 3 years in a management or team leadership role Extensive experience managing US IDE studies; thorough knowledge of FDA regulations (21 CFR 812), ICH E6(R2) GCP, and ISO 14155:2020 Demonstrated experience authoring regulatory and clinical documents including protocols, CSRs, CEPs/CERs, and annual progress reports Strong data interpretation skills with the ability to synthesize complex clinical results and present them clearly to scientific, regulatory, and lay audiences Prior experience with cardiac or implantable device studies strongly preferred; Class III medical device experience an advantage Can-do attitude, strategic thinker with strong leadership and cross-functional communication skills Willingness to travel to US clinical sites and attend key meetings and conferences as required What We Offer BiVACOR offers a competitive compensation package and comprehensive benefits, including: 401(k) with company matching Medical, dental, and vision insurance Health Savings Account (HSA) & Flexible Spending Account (FSA) Life insurance & Employee Assistance Program Generous paid time off This role may be based at BiVACOR’s Huntington Beach headquarters. The expected salary range for this position based in Huntington Beach California is $110,000 - $150,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting. Apply today and be part of something extraordinary. BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Compensation Range: $110K - $150K

Job Description POSITION SUMMARY: Reporting to the Director of Microbiology, the QC Microbiology Supervisor is responsible for overseeing the daily operations of the Quality Control Microbiology laboratory, ensuring compliance with cGMP regulations and company quality standards. This role includes supervising a team of Associates and Specialists, performing, and reviewing microbiological testing, overseeing laboratory equipment and supplies, and contributing to the development and implementation of quality systems. The Supervisor will also be responsible for data analysis, trend identification, and troubleshooting investigations related to microbiological excursions. This position requires strong leadership, technical expertise in microbiology, and a commitment to quality and continuous improvement. PRINCIPAL DUTIES: Execution of Microbiology Department Specific Tasks: • Extensive experience in Microbiology and EM groups and can lead actively and / or participate in technical projects pertaining to microbiology related testing processes, including but not limited to method development, transfer and validation activities, sanitization studies, media fill qualification activities, etc., • Reviews process and testing documentation as needed to ensure complete and accurate records are maintained., • Performs method validation/suitability for microbiological tests, specifically bioburden and sterility testing., • Performs trending analyses of data collected via environmental, personnel and utility monitoring in support of investigations, Quality Management Review, Annual Product Review, etc.; publish conclusions and make recommendations for process changes as applicable., • Investigates and documents any identified excursions or trends, including root cause analysis, impact assessment, and identification of corrective I preventive actions., • Plans and implements corrective and preventive actions (including procedure and test method revisions), and assists/measures the effectiveness of such changes., • Prepares weekly Environmental Monitoring/ Testing schedule., • Reviews and approves Bioburden, B&F, and Sterility testing reports., • Provides leadership, management, training, and career coaching for Micro Lab staff., • Oversee Gowning Qualification program at Pyramid Laboratories., • Authors technical protocols and reports for QC Microbiology., • Assists management in establishing operational objectives, goals, and project assignments., • Works through and solves complex projects/problems, where data and situation analysis are required. Process Optimization: • Assesses processes and procedure changes proposed by others for potential impact on environmental monitoring I microbiology testing processes., • Identifies inefficiencies in Microbiology workflows, communicates with quality leadership, and assists in implementation of improvements to enhance speed, accuracy, and compliance., • Participate in cross-functional meetings when needed and training sessions with manufacturing operations. Laboratory Support Activities: • Maintains qualification for all microbiology sampling procedures and test methods; performs testing as needed to support business needs., • Coordinates and/or conducts training for new laboratory personnel; provides technical assistance to laboratory personnel as needed., • Coordinates and/or conducts training for new laboratory personnel; provides technical assistance to laboratory personnel as needed., • Coordinates with contracts testing laboratories and experts as needed. Compliance & Audits: Ensure adherence to regulatory standards (e.g., FDA, ISO, GMP) and participate in internal audits and external inspections. Cross-Functional Collaboration: • Partner with manufacturing, R&D, and supply chain teams to ensure quality is embedded throughout the product lifecycle., • Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers. Metrics & Reporting: Develop and track KPI for Microbiology Performance presenting insights and recommendations to senior leadership. • Responsible for implementing LEAN concepts to continuously improve cycle times within the area of responsibility ., • Responsible for management of investigations, CAPAs, change control, requalification, and product annual review in the microbiology area., • Reviews data, to verify that ALCOA++ principles are being followed, accurate and in control before reporting., • Report nonconformances and follow escalation pathways., • Provide support and information as SME for the Pyramid facility during external and regulatory inspections., • May perform other duties as assigned. JOB REQUIREMENTS: Demonstrates proficiency in multiple quality systems including Deviation, CAPA and Out-of Specification management, Change Control, etc. with strong decision-making skills utilizing risk management. • Strong verbal, written and oral communication skills., • Strong knowledge of cGMP (US, EU, etc.) required, • Strong knowledge of manufacturing processes (Formulation, Filling, Packaging) and/or critical systems required., • Able to present areas of responsibility to regulatory agencies during inspections or external audits., • Proficient in problem solving using continuous improvement tools., • Attention to detail and strong documentation skills., • Team player with a continuous-improvement mindset., • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage, and conviction., • Must display personal accountability for results and integrity., • Must display eagerness to learn and continuously improve., • Must have uncompromising dedication to quality., • Must have relentless focus on rapid and disciplined action., • Must have respect for individuals and the diverse contributions of all. EDUCATION and/or EXPERIENCE: • Bachelor’s degree in biology, Chemistry, Pharmaceutical Sciences, Engineering, or equivalent experience preferred; or AS with relevant experience, • 3+ years of GMP/pharmaceutical experience preferred; experience in sterile or aseptic environments preferred.

Job Description Position Summary The Senior Validation Engineer is responsible for leading and executing validation activities supporting sterile injectable and biopharmaceutical manufacturing operations. This role ensures that facilities, utilities, equipment, computerized systems, and processes are designed, installed, qualified, and maintained in a validated state in compliance with FDA, EU GMP, ICH, and other global regulatory requirements. The position provides technical leadership, cross-functional collaboration, and subject matter expertise for aseptic processing, cleanroom environments, and contamination control strategies. Key Responsibilities Validation & Qualification • Lead and execute DQ, IQ, OQ, and PQ activities for aseptic filling lines and isolators/RABS, Autoclaves, SIP/CIP systems, Lyophilizers, Sterile filtration systems, cleanrooms and classified areas., • Author, review, and approve validation protocols, perform and support executions, interpret and review data, and write final reports., • Develop and maintain Validation Master Plans (VMPs)., • Experience with process and cleaning validations and aseptic process simulations (media fills)., • Lead validation of critical utilities such as Water for Injection (WFI), clean steam, HVAC systems and Compressed gases (CDA, and nitrogen)., • Execute environmental qualification and airflow visualization (smoke studies)., • Validate computerized systems in accordance with GAMP 5 and 21 CFR Part 11., • Ensure data integrity compliance (ALCOA+ principles)., • Support automation and control systems validation (PLC, SCADA, etc.)., • Ensure validation activities comply with FDA cGMPs (21 CFR Parts 210, 211), and EU GMP Annex 1 (Sterile Manufacturing)., • Support regulatory inspections, customer audits and responses to audits. Technical Leadership & Continuous Improvement • Act as Subject Matter Expert (SME) for validation and sterile manufacturing., • Lead change controls, deviations, CAPAs, and risk assessments (FMEA)., • Drive continuous improvement initiatives to enhance compliance, efficiency, and robustness. Required Education • Bachelor’s degree in Engineering or related Life Sciences field., • Excellent technical writing and documentation skills and MS Office (Word, Excel, PowerPoint, etc.). Experience • 7+ years of hands-on experience in validation of sterile injectable pharmaceutical or biopharmaceutical industry.

Job Description POSITION SUMMARY: The Associate Director of Manufacturing is responsible for training and supervising manufacturing personnel while leading GMP-compliant fill/finish operations. This role oversees the execution of manufacturing activities, ensuring proper documentation, reporting, and record management. Provides leadership support for equipment monitoring, troubleshooting, maintenance, and validation to ensure efficient and compliant manufacturing processes PRINCIPAL DUTIES: • Execute and/or monitor the Manufacturing processes and procedural activities as required for a GMP compliant Fill/Finish operation., • Serve as Subject Matter Expert (SME) in aseptic operations, including filling and preparation activities such as washing, autoclaving, formulation and associated support processes,, • Manage, initiate and oversee the set-up of manufacturing equipment including activities required for validation activities. Assist in designing and executing validation protocols and or machinability studies., • Support the preparation and execution of validation related qualification documents and the resourcing of associated tasks (engineering batches, aseptic process simulation, validation activities)., • Develop and implement operator training strategies, including qualification plans, technical training, aseptic behavior training, and knowledge transfer for new products., • Skilled in troubleshooting various equipment as required for the manufacturing process., • Perform technical evaluation of manufacturing related information and provide management with status reports including information required for decision-making purposes., • Writing and/or review of Process Support operational documentation (Master Batch Records, SOPs, Work Instructions, Deviations, CAPAs Change Controls, Complaints)., • Directly accountable for production schedule adherence., • Train, mentor and supervise employees within manufacturing areas., • Ensure that manufacturing systems and processes are effective and compliant and can be defended to regulatory agencies., • Initiate problem solving, trouble-shooting and technical decision-making commensurate with level of experience., • Strong knowledge of GMP procedures and requirements, as related to the position., • Ability to set-up, maintain and perform various manufacturing related activities as required for a GMP compliant Fill/Finish operation., • Ensure batch records and logbooks are completed and reviewed in a timely manner to support batch release., • Train and supervise employees within manufacturing areas, as applicable. Ensure all training is thorough and documented., • Perform various manufacturing duties according to the GMP guidelines and initiate appropriate documentation as required including all forms, logs, batch records, etc., according to the applicable SOPs., • Ensure staff maintains and tracks manufacturing supplies and product specific materials within the manufacturing areas. Manage and ensure that all activities within the ERP system are completed real time to ensure accurate inventory levels and usage., • Written and oral skills at a level commensurate for interaction with staff, vendors, clients, and auditors as necessary. QUALIFICATIONS & EXPERIENCE: • A minimum of BS is Chemical Engineering, Biology, or life science, with and advanced degree (MS) preferred, or equivalent relevant experience., • 10 – 12 years of relevant experience in the pharmaceutical industry, with at least 5 years in a leadership role., • Strong knowledge of Drug Product manufacturing technologies and processes to include:, • Vial Lines (stoppering and capping), • Syringe Lines within RABS, • Cartridge lines, • Manual filling equipment, • Knowledge of cGMP, FDA, DEA, and related international regulations.

Job Description Clinical Research Coordinator – RN II Location: Newport Beach, CA Salary: $52 – $75 per hour Based on the years of experience Job Type: Direct Hire | Full-Time | Onsite Position Overview: We are seeking a Clinical Research Coordinator – RN II to manage and coordinate complex clinical research trials including drug, device, and biologic studies across Phase I–IV trials. This role works closely with physicians, sponsors, and research teams to ensure compliance with Good Clinical Practice (GCP), FDA regulations, and human subject protection standards. Schedule: Full-Time Mon – Fri 8:30 AM – 5:00 PM Key Responsibilities: • Manage and coordinate complex clinical research trials including industry-sponsored, government-funded, and investigator-initiated studies., • Conduct protocol review and study preparation prior to trial initiation., • Manage the informed consent process according to regulatory standards., • Recruit, screen, and assess study participants based on eligibility criteria., • Collect and process laboratory samples in compliance with IATA standards. Required Qualifications: • 2+ years of clinical research experience or equivalent training, • Active Registered Nurse (RN) license – California, • Basic Life Support (BLS) Certification, • Knowledge of Good Clinical Practices (GCP), FDA regulations, and human subject protection, • Strong organizational, analytical, and communication skills, • Proficiency in Microsoft Word, PowerPoint, and Windows applications, • Ability to work in a fast-paced research environment Preferred Qualifications: • Bachelor of Science in Nursing (BSN), • Knowledge of FDA, NIH, and OHRP regulatory requirements, • Experience with Institutional Review Board (IRB) documentation, • Understanding of clinical trial methodologies, • ACRP or SoCRA certification, • IATA certification TS Company DescriptionLanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.

Job DescriptionHelp Us Build the Future of the Human Heart. At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients a second chance at life. If that's the kind of work that gets you out of bed in the morning, we'd love to meet you. About the Role This is a high-impact leadership role at the intersection of quality engineering strategy and clinical-stage medical device development. As Senior Manager, Quality Engineering, you will serve as a principal leader within the BiVACOR quality organization, responsible for architecting and directing quality engineering functions across the full product lifecycle of the Total Artificial Heart (TAH) system, one of the most technically advanced implantable devices in development today. This elevated role demands a visionary, technically authoritative, and operationally excellent leader with deep expertise in electrical engineering and a distinguished track record with Class III Active Implantable Medical Devices (AIMD). You will not only lead the QE team in verification and validation, manufacturing process quality, supplier controls, and regulatory compliance — you will define the strategic direction of quality engineering programs, drive enterprise-level QMS maturity, and serve as a senior executive liaison across quality, engineering, manufacturing, regulatory affairs, and clinical functions. You will mentor and grow quality engineering talent, shape organizational quality culture, and partner with senior leadership to advance BiVACOR’s mission of bringing a life-saving total artificial heart to patients. Key Responsibilities Quality System Leadership & Strategy Define and execute the strategic vision for the QMS, aligned with ISO 13485, 21 CFR Part 820, 803, and 806 Serve as the senior quality engineering authority for BSI surveillance audits and FDA inspections Lead and develop a high-performing quality engineering team, providing strategic direction and career development Establish enterprise-wide quality KPIs and present strategic recommendations to executive leadership Verification, Validation & Design Assurance Direct V&V planning, execution, and documentation for electrical, software, and system-level protocols supporting IDE and PMA submissions Approve test protocols and reports, ensuring traceability to design inputs and applicable standards (ISO 14708, IEC 60601, ISO 14971) Oversee test method validation (TMV) and equipment qualification (IQ/OQ/PQ) programs Manufacturing Quality & Nonconformance Architect and enforce IPC-A-610 workmanship standards for electronic assemblies across the TAH system Own the nonconformance (NC) and QCIR programs, including MRB disposition, root cause investigation, and CAPA linkage Drive systemic resolution of manufacturing quality escapes with root cause rigor Risk Management & CAPA Lead FMEA, FTA, and risk management file strategy at the program level per ISO 14971 Own and govern the enterprise CAPA process from initiation through effectiveness verification Evaluate field performance data and clinical feedback to identify and mitigate systemic quality risks Supplier Quality Architect and lead the end-to-end supplier quality program: qualification, performance monitoring, audits, and corrective actions Conduct strategic on-site audits with focus on high-risk and sole-source AIMD-critical suppliers Partner with engineering and procurement to assess supply chain risk and maintain the approved supplier list (ASL) Cross-Functional & Regulatory Leadership Serve as the senior quality engineering representative in executive program reviews and manufacturing readiness assessments Lead quality engineering strategy for IDE supplements, PMA modules, and FDA information requests Influence and align R&D, Regulatory Affairs, Software, and Manufacturing Engineering on quality strategy throughout the product lifecycle Continuous Improvement Define and lead the organizational continuous improvement strategy using Lean, Six Sigma, or equivalent methodologies Sponsor initiatives to reduce defect rates, improve first-pass yield, and optimize QMS processes Present improvement initiative outcomes and strategic impact to executive leadership What You Bring Bachelor’s degree or higher in Electrical Engineering (mandatory) Minimum 18 years of experience in the medical device industry, including demonstrated senior quality engineering leadership Direct experience with Class III Active Implantable Medical Devices (AIMD), including deep knowledge of FDA IDE/PMA regulatory requirements IPC-A-610 and/or IPC-A-620 certification strongly preferred Technical Expertise Expert knowledge of IEC 60601 series, ISO 14971, ISO 13485, and 21 CFR Part 820, 803, and 806 Deep experience with electrical and electromechanical system qualification for implantable devices Proficiency in FMEA, FTA, statistical analysis, MSA/Gage R&R, and reliability methodology Experience with EO sterilization qualification, cleanroom operations, and QMS software platforms Leadership & Influence Proven track record of building and inspiring senior quality engineering teams Demonstrated ability to influence executive stakeholders and drive enterprise-level quality strategy Experience representing quality at a senior level in FDA or notified body inspections Track record of leading cross-functional V&V programs for complex regulatory submissions Highly Desirable VAD or Total Artificial Heart experience ASQ certification (CQE, CQM/OE, or CRE) Familiarity with Enlil, Arena, or comparable QMS/PLM platforms Experience with IDE clinical studies and associated quality system requirements The expected salary range for this position based in Huntington Beach California is $155,000 - $169,990. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting Apply today and be part of something extraordinary. BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Compensation Range: $158,000 - $169,992

Job Description Duties: Job Summary: The Clinical Research Coordinator-Registered Nurse II (CRC RN-II) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians, inter- and intradepartmental stakeholders, and sponsors. The position is responsible for managing complex clinical research trials including drug, device, and biologic studies across Phase I, II, III, and IV clinical trials, government-funded research, and investigator-initiated studies while ensuring compliance with Good Clinical Practice standards, human subject protection regulations, and FDA guidelines. Job Responsibilities: Manages complex clinical research trials including industry-sponsored, government-funded, and investigator-initiated studies. Maintains compliance with Good Clinical Practices, FDA regulations, and human subject protection standards. Provides overall study management, coordination, and operational support for assigned research trials. Performs protocol review and preparation activities prior to study initiation. Administers and manages the informed consent process in accordance with regulatory requirements. Conducts subject recruitment, screening, and eligibility assessments based on inclusion and exclusion criteria. Collects, processes, and documents laboratory samples in compliance with International Air Transport Association standards. Ensures completion of all protocol-required clinical assessments and procedures. Accurately collects, records, and enters study data into clinical research databases while maintaining data integrity and quality. Completes case report forms and addresses data queries in a timely manner. Monitors and reports adverse events according to protocol and regulatory requirements. Maintains regulatory binders and study documentation in accordance with sponsor and regulatory standards. Develops study flow sheets and prepares study source documentation. Hosts and participates in study team meetings and site initiation visits. Assists with cost analysis, study budget preparation, and tracking and distribution of study funds. Supports the growth and strategic vision of the Institute for Research and Education. Assists with training and mentoring other Clinical Research Coordinators as needed. Promotes team building and fosters a positive and respectful work environment. Performs other duties as assigned. Skills: Required Skills & Experience: Two (2) or more years of experience performing clinical research duties or equivalent experience and training. Excellent analytical and problem-solving skills. Excellent verbal and written communications and presentation skills; excellent organizational skills; close attention to detail and excellent interpersonal skills to work effectively in a diverse team. Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects. Ability to establish cooperative working relationships with patients, co-workers, & physicians. Behaves in a professional manner in all settings and promotes team building. Follows policies set by the organization and department.Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines. Understanding of clinical trial methodologies and experience filing Institutional Review Board documents. Ability to abstract data from medical records and transfer it to data collection forms or directly into databases. Proficiency with Microsoft Word, PowerPoint, and Windows. Preferred Skills & Experience: N/A Required Skills & Experience: Two (2) or more years of experience performing clinical research duties or equivalent experience and training. Knowledge of Good Clinical Practices, protection of human subjects, and FDA regulatory guidelines. Excellent verbal and written communication skills. Strong organizational skills with close attention to detail. Excellent interpersonal skills to work effectively within a diverse team environment. Strong analytical and problem-solving skills. Proficiency in Microsoft Word, PowerPoint, and Windows-based applications. Ability to work effectively in a fast-paced, team-based environment. Project management and coordination skills with the ability to prioritize tasks and meet multiple deadlines. Ability to establish and maintain cooperative working relationships with patients, physicians, and coworkers. Ability to behave professionally in all work settings and promote team-building behaviors. Ability to follow organizational and departmental policies and procedures. Ability to travel locally between organization locations as required. Preferred Skills & Experience: Working knowledge of FDA, NIH, and OHRP regulatory requirements. Working knowledge of ICH Good Clinical Practice guidelines. Understanding of clinical trial methodologies. Experience filing Institutional Review Board documentation. Ability to abstract data from medical records and transfer information into data collection forms or electronic databases. Education: Required Education: High School Diploma. Preferred Education: Bachelor of Science in Nursing (BSN) Degree or higher. Required Certifications & Licensure: Current licensure in good standing as a Registered Nurse in the State of California. Basic Life Support (BLS) Certification. Preferred Certifications & Licensure: Current ACRP Certification. OR SoCRA Certification. Nursing Specialty Certification. International Air Transport Association (IATA) Certification. Languages: English Read Write Speak Certifications & Licenses: Basic Life Support (BLS) Certification Registered Nurse licensure in the State of California

Job Description Help Us Build the Future of the Human Heart. At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients another shot at life. If that's the kind of work that gets you out of bed in the morning, we think you belong here. About the Role This is a high-impact technical leadership role in an FDA-regulated, Class III medical device environment, specializing in PCBA, cable and harness manufacturing, controller assembly, and battery systems. As BiVACOR's subject matter expert for electrical workmanship and manufacturing quality, you will set technical direction, lead cross-functional teams, and help bring the world's first Total Artificial Heart to patients. Key Responsibilities Lead the design, development, and strategic improvement of electrical manufacturing processes including PCBA, cable and harness assembly, controller assembly, and battery pack build Own and lead process validations (IQ, OQ, PQ, PPQ) for all electrical manufacturing processes ensuring full FDA, ISO 13485, GMP, and IPC 610/620 Class 3 compliance Champion Lean and Six Sigma methodologies, driving measurable reductions in defects, cycle time, and rework across electrical assembly operations Lead NC/CAPA investigations for electrical assemblies, applying Six Sigma and fault tree analysis to drive root cause resolution and eliminate systemic issues Lead the qualification and development of suppliers for electrical components, PCBAs, cable and harness assemblies, batteries, and electronic sub-assemblies Conduct supplier audits and performance reviews, driving continuous improvement across the supply base Establish and maintain comprehensive electrical manufacturing documentation including BOMs, work instructions, solder/crimp process specifications, and test procedures Lead cross-functional collaboration with Electrical R&D, Quality, Supply Chain, and Regulatory teams as the senior manufacturing engineering voice for all electrical assemblies Mentor and develop Manufacturing Engineers at junior levels (I–III), providing technical guidance, coaching, and structured feedback Lead and manage complex, cross-functional manufacturing engineering projects from initiation through completion What You Bring BS in Electrical, Mechanical, Biomedical, or Manufacturing Engineering — MS desirable Medical device or other highly regulated industry manufacturing experience (Class II or III device experience preferred) 8+ years of engineering experience with a strong focus on electrical manufacturing including PCBA assembly, cable and harness manufacturing, and electronic sub-system build IPC-A-610 CIS or CIT certification at Class 3 level (Required) — IPC-A-620 Class 3 certification strongly preferred Deep expertise in electrical process characterization, pFMEAs, IQ/OQ/PQ/PPQ, and TMVs — with a track record of owning validation programs end-to-end Comprehensive knowledge of ISO 13485 and FDA QSR (21 CFR Part 820) with experience supporting regulatory submissions and audits In-depth knowledge of IPC-610, IPC-620, IPC-A-600, J-STD-001, and WHMA-A-620 standards Advanced problem-solving skills with structured methodology — Six Sigma Black Belt strongly preferred: PMP certification an advantage Demonstrated supplier development and management experience for electronic components and assemblies What We Offer BiVACOR offers a competitive compensation package and comprehensive benefits, including: 401(k) with company matching Medical, dental, and vision insurance Health Savings Account (HSA) & Flexible Spending Account (FSA) Life insurance & Employee Assistance Program Generous paid time off The expected salary range for this position based in Huntington Beach California is $120,000 - $155,00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting Apply today and be part of something extraordinary. BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Compensation Range: $145K - $150.8K

Job Description Help Us Build the Future of the Human Heart. At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients another shot at life. If that's the kind of work that gets you out of bed in the morning, we think you belong here. About the Role We are seeking an experienced QMS Internal Auditor to plan, execute, and report on internal quality system audits in accordance with ISO 13485:2016, 21 CFR Part 820, and FDA IDE requirements. This individual will serve as a key contributor to BiVACOR's ISO 13485 certification readiness program and ongoing QMS surveillance activities, reporting directly to the Director of QA & Regulatory Affairs. Key Responsibilities: Audit Planning & Execution Develop and maintain the annual internal audit schedule based on risk, regulatory requirements, and process criticality. Lead and conduct internal audits of all QMS processes, including design controls, production & process controls, CAPA, complaint handling, supplier quality, document/record control, sterilization, and clinical device release. Author audit plans, checklists, and reports in accordance with ISO 13485 and 21 CFR Part 820 requirements. Coordinate with process owners and subject matter experts to schedule and execute audits with minimal disruption to operations. Findings Management & CAPA Document nonconformities, observations, and opportunities for improvement with clear objective evidence. Assign and track audit findings through closure, including verification of CAPA effectiveness. Collaborate with CAPA owners to ensure root cause analyses are thorough and corrective actions are implemented on schedule. ISO 13485 Certification & Regulatory Support Support third-party certification body (CB) audits and surveillance activities, including readiness assessments, escort duties, hosting audits, and CB interface coordination. Assist with preparation and review of QMS documentation for CB audit submissions. Provide gap analysis and remediation support against ISO 13485:2016 and 21 CFR Part 820 / Quality System Regulation (QSR). Support IDE compliance activities under 21 CFR Part 812 as needed, including clinical device release audit trail review. Audit Program Management Maintain the internal audit program, including audit procedure governance, auditor qualification records, and audit metrics reporting to QA leadership. Track and trend audit findings to identify systemic quality issues and improvement opportunities. Support training of staff on internal audit methods and quality system requirements. Travel Travel domestically and internationally as required to support multi-site audits, supplier audits, CB audits, or clinical site quality oversight activities (estimated up to 20-30% travel). What You Bring Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or a related technical discipline. Minimum 10 years of experience in Quality Assurance within the medical device industry. Minimum 5 years of direct internal auditing experience against ISO 13485 and/or 21 CFR Part 820. Experience with Class III and/or Active Implantable Medical Device (AIMD) development and commercialization strongly preferred. Demonstrated experience supporting or participating in third-party CB certification audits (ISO 13485). Familiarity with FDA IDE regulations (21 CFR Part 812) and clinical device release processes preferred. Thorough working knowledge of ISO 13485:2016 and 21 CFR Part 820 (QSR/QMSR). Working knowledge of ISO 14971 (risk management), IEC 62304 (software lifecycle), and/or ISO 10993 (biocompatibility) a plus. Proficiency with electronic QMS platforms (e.g., Enlil, ZenQMS, MasterControl, Veeva, or equivalent). Certifications (Required — at least one) ISO 13485 Lead Auditor certification (e.g., IRCA, Exemplar Global, or equivalent accredited body), OR ASQ Certified Quality Auditor (CQA), OR ASQ Certified Quality Engineer (CQE) with documented lead auditor training. Preferred Qualifications Experience auditing sterilization processes (e.g., EO, radiation) and/or sterile medical device manufacturers. Exposure to Class III AIMD regulatory submissions (PMA, IDE) or design history file (DHF) review. Experience in a startup or scale-up medical device environment building QMS infrastructure. Familiarity with supplier quality management and supplier audit execution. Experience with ISO 13485 certification pursuit from gap assessment through initial certification. What We Offer BiVACOR offers a competitive compensation package and comprehensive benefits, including: 401(k) with company matching Medical, dental, and vision insurance Health Savings Account (HSA) & Flexible Spending Account (FSA) Life insurance & Employee Assistance Program Generous paid time off The expected salary range for this position based in Huntington Beach California is $126,000 to $138,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting Apply today and be part of something extraordinary. BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Compensation Range: $126K - $138K

Job Description For over fifty years, Custom Power has been at the forefront of designing and manufacturing specialized battery packs and advanced battery management systems. Serving vital industries such as medical, aerospace, defense, and industrial – from the depths of the ocean to the fringes of space – our team of expert design engineers collaborates closely with clients. We utilize a broad spectrum of chemistry technologies to develop the perfect battery solution. Offering both primary and secondary chemistries, we adhere to international standards such as UL, IEC, CE, and CSA. As an ISO 9001, AS9100, and ITAR-registered company, Custom Power is committed to delivering unparalleled quality and versatility in our battery solutions. Responsible for design and validation of electronic circuits, and specification and programming of electronic test equipment. This position requires good communication skills and effective teamwork. All projects involve collaborating within a multidisciplinary team to design a battery pack. The candidate will be responsible for designing, prototyping, testing, and transitioning electronic circuits, interfaces, cables, accessories, and their corresponding documentation to manufacturing. From your very first day of employment with us, your success will be our top priority. You'll be paired with our Global Battery Technologist for mentoring and support, ensuring you are part of an organization that values your development and well-being and is dedicated to making every workday rewarding. Additionally, you'll have the opportunity to engage in various aspects of design and battery pack development, encompassing a wide range of designs and applications for some of the largest and most dynamic companies in the world. ESSENTIAL DUTIES AND RESPONSIBILITIES • Circuit Design: Develop and design analog and digital electronic circuits for battery packs of various chemistries, ensuring optimal performance, efficiency, and safety., • Battery Charger Systems Development Integration: Develop and Incorporate battery charger systems into circuit designs, considering charging efficiency, safety, and compatibility with various battery chemistries., • Component Selection: Identify and select appropriate components, such as voltage regulators, protection circuits, monitoring systems, and battery chargers, to meet project requirements., • Schematic Capture: Utilize Altium Designer for detailed schematics, ensuring accurate representation of circuit configurations., • PCB Layout: Design and optimize printed circuit boards (PCBs) using Altium Designer, considering factors like signal integrity, thermal management, and manufacturability., • DFM (Design for Manufacturing): Take ownership of Design for Manufacturing principles, ensuring that circuit designs are conducive to efficient and cost-effective production processes., • DFT (Design for Testability): Implement Design for Testability strategies in circuit designs, enabling effective testing and troubleshooting during the manufacturing phase., • BMS Development: Collaborate with Firmware Engineers to develop Battery Management Systems (BMS) firmware, ensuring efficient and safe battery operation., • Fuel Gauge Integration: Work closely with Firmware Engineers to integrate fuel gauging solutions into battery pack designs, providing accurate state-of-charge information., • APQP (Advanced Product Quality Planning): Apply APQP methodologies to ensure robust, high-quality circuit designs., • PPAP (Production Part Approval Process): Execute PPAP requirements, providing the necessary documentation to validate and approve the manufacturing processes., • Prototyping: Collaborate with cross-functional teams to build and test prototypes, iterating designs based on testing outcomes., • Compliance: Ensure designs comply with relevant industry standards, including those set by the United Nations (UN) for the transportation and handling of lithium-ion batteries. Adhere to Underwriters Laboratories (UL) standards for safety and performance in battery pack designs., • Documentation: Maintain comprehensive documentation of development, product design, specifications, and testing results in accordance with company process and regulatory requirements and standards such as UN, UL, IEC, AS, FDA., • Collaboration: Work closely with other engineers, including, Mechanical, Firmware, Technicians, and Project Managers to achieve project goals within specified timelines., • Problem Solving: Troubleshoot and resolve issues related to, BMS Systems including, circuit design, firmware, integration, cells, and battery charging systems. QUALIFICATIONS • Bachelor’s degree in electrical engineering or a related field; Master's degree is a plus., • 10+ years of experience in electronics technology and embedded hardware., • 8+ years designing Battery Management Systems for battery applications., • Preferred experience in the design of circuits for lithium-ion battery packs., • Proven experience with analog and digital circuits and power system design., • Proficiency in using Altium Designer for schematic capture and PCB layout., • Experience with the integration of battery charger systems into circuit designs., • Familiarity with thermal management in battery pack designs., • Knowledge of energy storage systems and renewable energy applications., • Experience with ownership of DFM and DFT principles., • Experience with APQP and PPAP requirements in the product development process., • Experience collaborating with Firmware Engineers for BMS and fuel gauge development., • Familiarity with relevant UN and UL industry standards and regulations., • Excellent problem-solving skills and attention to detail., • Effective communication and collaboration skills within cross-functional teams., • Must communicate effectively in English (Written and Verbal) Custom Power is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. This position must meet export control compliance requirements. To meet export control compliance requirements, a “U.S. Person” as defined by 22 C.F.R. §120.15 is required. “U.S. Person” includes U.S. Citizen, lawful permanent resident, refugee, or asylee. To conform to U.S. Government space technology export regulations, including the International Traffic in Arms Regulations (ITAR) you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.

Job Description Help Us Build the Future of the Human Heart. At BiVACOR, we’re developing the world’s most advanced total artificial heart, a technology capable of saving millions of lives around the world. We’re a team united by purpose, working on something truly unprecedented. Every data query you resolve, every site relationship you build, and every protocol you uphold plays a direct role in giving patients another shot at life. If that’s the kind of work that gets you out of bed in the morning, we think you belong here. About the Role BiVACOR is looking for a highly motivated Clinical Research Specialist who is well-versed in clinical trial management. In this role, you will oversee trial sites, manage the documentation and data collected during studies, and serve as a key liaison between BiVACOR and investigational site teams. Your collaboration with clinical sites is critical to ensuring trials are conducted ethically while adhering to protocol, applicable regulations, and guidelines — helping us move closer to putting the world’s first Total Artificial Heart into the hands of patients who need it most. Key Responsibilities Serve as key contact for Clinical Site Research Coordinators and liaise to ensure timely, accurate entry of data into the eCRF, including resolution of data queries Provide training to study staff on study protocols and GCP guidelines Develop and maintain study timelines and budgets Develop study documents and procedures, and conduct study site file (eTMF) maintenance reviews Review and maintain clinical trial documents (e.g. informed consents) and analyze clinical trial data for accuracy and completeness Perform investigational product (IP) inventory, reconciliation, and review of storage and security Ensure sites are conducting activities per protocol, HREC requirements, and executed contracts Provide frequent communication to study leadership on site status updates Work closely with the extended study team, including CROs, vendors, and trial staff Follow standard operating procedures and Good Clinical Practice (GCP) guidelines What You Bring Bachelor’s degree in a life science-related field; advanced degree may substitute for years of experience 2–4 years of experience in a clinical trials research environment or equivalent General knowledge of regulatory requirements (e.g. TGA, FDA) and Good Clinical Practices (GCP) CCRA, ACRP, CCRP, SOCRA certification or equivalent preferred Proficient knowledge of medical terminology and clinical trial documentation requirements, including eTMF management Strong interpersonal, collaborative, and time management skills; excellent organizational and communication abilities Can-do attitude, detail-oriented and the ability to manage shifting priorities and work across a global team Willingness to travel nationally and internationally up to 75% as required to support clinical site activities What We Offer BiVACOR offers a competitive compensation package and comprehensive benefits, including: 401(k) with company matching Medical, dental, and vision insurance Health Savings Account (HSA) & Flexible Spending Account (FSA) Life insurance & Employee Assistance Program Generous paid time off The expected salary range for this position based in Huntington Beach California is $90,000 to $118,000 annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting Apply today and be part of something extraordinary. BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Compensation Range: $90K - $118K

Job Description Clinical Research Coordinator – Registered Nurse This position is 100% onsite Location: Onsite – Newport Beach, CA ???? Schedule: Monday–Friday, 8:30 AM – 5:00 PM ???? Hourly Pay (Contract): $43.00/hour Position Summary The Clinical Research Coordinator – Registered Nurse II (CRC RN-II) plays a critical role in the execution of complex clinical research studies at Hoag. This position is responsible for the end-to-end coordination and management of clinical trials, working closely with study physicians, sponsors, and cross-functional teams to ensure compliance with Good Clinical Practice (GCP), FDA regulations, and human subject protection standards. Key Responsibilities Manage complex clinical research trials (industry-sponsored, government-funded, and investigator-initiated) Ensure compliance with GCP, FDA regulations, and human subject protection requirements Provide overall study coordination, management, and operational support Required Certifications & Licensure Active Registered Nurse (RN) license in the State of California Basic Life Support (BLS) Certification Education Required: High School Diploma Preferred Skills & Experience Knowledge of FDA, NIH, and OHRP regulatory requirements Working knowledge of ICH Good Clinical Practice guidelines Understanding of clinical trial methodologies ???? How to Apply Qualified candidates with an active California RN license are encouraged to apply. Please send your resume and licenses to: staffing@huckeyehealthstaffing For questions, reach us at: (281)-769-8184

Turing invites Healthcare and FDA Regulatory Law experts to join projects that fine-tune AI models like ChatGPT. You will apply your expertise in healthcare compliance, FDA drug/device approval, Anti-Kickback Statute analysis, and HIPAA enforcement to evaluate how AI handles healthcare regulatory sc