Regulatory affairs jobs in San Diego, CACreate job alerts

Job Title: Supplier Quality Engineer Location: San Diego, CA (On-site) Job Type: Permanent, Full Time An innovative medical device start-up located in San Diego, developing next-generation Class II active medical devices aimed at improving patient outcomes and quality of life are seeking an...

JCW Search is working on an exciting search for a 3-month consultant to join a Diagnostics Company on site in San Diego. The ideal candidate will have the following qualifications/responsibilities: - 5+ years of IVD experience - Knowledge of technical documentation: 510(k)s, EU IVDR - Abil...

Job Description SUMMARY: The Student Affairs Coordinator is responsible for assisting the Student Affairs department in all student progress and retention efforts. Guided by the Director, this position will work with students in one-on-one and group settings to help ensure student’s success throu...

Job DescriptionAbout Truvian Truvian is a fast-paced and disruptive healthcare company at the intersection of diagnostics and consumer technology. We are developing a fully automated benchtop system that delivers lab-accurate results from a small blood sample under 30 minutes—designed for use in ...

Job DescriptionSummary Reporting to the Sr. Director of Clinical Operations, the Clinical Trials Manager is responsible for overseeing and executing the operational aspects of one or more clinical studies from protocol development through database lock. This role ensures the timely conduct of cl...

Job Description JOB SUMMARY The Senior/Clinical Program Manager of Clinical Operations is responsible for leading the operational planning and execution of one or more clinical trials from study start-up through completion. This role ensures that clinical studies are conducted in accordance wit...

We are seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. Assist in the development and implementation of regulatory strategies and update stakeholders on regulatory developments affecting the company’s products. Bachelor’s degree in Life Scienc

Lead the Regulatory Affairs team in managing global clinical regulatory activities, including strategy development, regulatory submissions (IND/CTA, NDA/BLA/MAA), and health authority interactions across all development phases. Hold a BS/MS/PhD in life sciences with 12+ years of progressive Regul...

Experience in authoring and reviewing CMC regulatory documents for regulatory submissions. Contribute to the development and maintenance of Regulatory Intelligence to anticipate regulatory trends and requirements impacting CMC strategies. Manager Level: Minimum 5+ years of experience in CMC Regul...

Job DescriptionSalary: About Artiva: Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead product candidate, AlloNK, is a non-genetically modified, ...

Job Description About INOVIO INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO’s technology optimizes the design and delivery of innovative DNA medicines th...

Job DescriptionAbout Radionetics Radionetics Oncology, Inc. is a clinical stage company focused on the discovery and development of novel radiopharmaceuticals for the treatment of a wide range of oncology indications and is poised to capitalize on the increasing demand for novel radiotherapeutics...

Job Description About INOVIO INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO’s technology optimizes the design and delivery of innovative DNA medicines th...

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical...

Job DescriptionDescription: The Chief Medical Officer, “CMO” will work as a strategic partner with other members of the senior executive team to develop and advance their clinical development strategy and drive the clinical research vision and regulatory roadmap for the company. The CMO will have...

Job Description Who we are: Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the ...

Associate Director, CMC Regulatory Affairs. Sr Regulatory Affairs Specialist (Remote) - Shockwave. Senior Specialist, Regulatory Affairs - Hybrid.

A highly experienced life science team driving forward its vision of significantly improving metabolic health outcomes.At Skye Bioscience, our focus is to contribute new mechanisms and drugs with the potential to help build the mosaic of therapeutic approaches and benefits that are necessary to s...

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender tran...

Regulatory Affairs and Commercial Counsel, you will be a critical member of the Legal team, as the primary regulatory counsel for the Sony Electronics business in the US and Canada. The Regulatory Affairs and Commercial Counsel will report to the Assistant General Counsel and will also be expecte...

Provide mentorship and oversight of Regulatory Affairs staff to plan, manage, author, coordinate, and review regulatory submission documents and development activities to support regulatory filings and dossier lifecycle. Fate Therapeutics is looking for an Executive Director or Senior Director in...

Minimum of 5 years of strong Regulatory Affairs/Compliance experience in medical devices. Knowledge of global Regulatory Affairs requirements, regulations, and standards. Excellent interpersonal, communication, and analytical skills and able to partner with cross-functional colleagues to identify...

Independent from RA Management, a Regulatory Affairs Specialist V is responsible for:. Broadly recognized as a Regulatory Expert in US, EU, and other regional Regulatory filings. Assisting the RA manager with training and direction of regulatory affairs.

The Senior Regulatory Affairs Specialist overseeing advertising and promotional Regulatory responsibilities, works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. The Senior Regulatory Affairs Specialis...

This position will report to the Director, Regulatory Affairs and collaborate with regulatory and other departments to ensure alignment and consistency in regulatory strategies and submissions. This position is responsible for supporting multiple global regulatory projects, ensuring compliance wi...

The individual will build and develop the marketing organization, structure, and capabilities, ensuring seamless cross-functional collaboration with sales, market access, medical affairs, analytics, R&D, regulatory, finance, and other key functions. Oversee digital and tactical marketing initiati...

Job Description Job Description: We are seeking an experienced, collaborative, strategic physician to build and realize the vision for the Company’s portfolio by helping build and execute clinical trial strategy. This is a leadership role that requires proven abilities to drive both strategic in...

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical...

Job Description At Modular Medical, our goal is to simplify diabetes management, ensuring that everyone has access to the superior care that insulin pumps offer. We believe that managing diabetes should be empowering, not intimidating. You shouldn’t have to be a tech expert or a math genius to ta...

Job Description Who we are: Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the ...

Job DescriptionPosition Overview:The Director of Regulatory Affairs will oversee regulatory activities related to IND/CTA preparations and maintenance, supporting both new and ongoing development programs. This role requires a self-directed, motivated regulatory professional. The position is base...

Job DescriptionRegulatory Affairs Staff SpecialistLocation: San Diego, CA (Onsite) Salary Range: $120,000 - $147,000 Job SummaryBioPhase is seeking a Regulatory Affairs Staff Specialist to support regulatory compliance and product registrations for in vitro diagnostic (IVD) products. This role wi...

Job DescriptionDirector/Executive Director, Clinical Development Company: BioPhase Solutions Location: San Diego, CA Salary: $190k - $325k Yearly About BioPhase BioPhase is a leading provider of talent solutions in the biotechnology and pharmaceutical sectors, specializing in clinical development...

Job Description Summary:Clinical Science Liaison in the US Marketing Organization for Triage POC, this role involves promoting and supporting strategic initiatives in alignment with the Sales Organization. Key responsibilities include the promotion of strategic assays (Triage) which focus on dise...

Job DescriptionChief Medical Officer (CMO) San Diego, CA $350,000 - $470,000 About the Role BioPhase is partnering with a cutting-edge biotech company to hire a Chief Medical Officer (CMO). This executive will lead clinical development strategy, oversee regulatory efforts, and represent the compa...

Job Description Is it time to begin the next chapter of your career? Are you looking to take charge of your sales success and enjoy an uncapped commission plan? Would you like to be part of an amazing team that is driving positive change in the animal health industry? We invite you to join us on...

Job DescriptionCompany Description ORIC is a research-driven company dedicated to discovering and developing novel therapies that can Overcome Resistance In Cancer. Our collaborative, empowering culture gives scientists the authority, responsibility, and support to do cutting-edge work on thera...

Job Description Who we are: Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the ...

Job DescriptionRegulatory Affairs ManagerLocation: San Diego, CA (Onsite) Salary Range: $145,000 - $165,000Job SummaryBioPhase is seeking a Regulatory Affairs Manager to lead regulatory strategy and compliance for in vitro diagnostic (IVD) products. This role oversees regulatory submissions, mark...

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical...

Job DescriptionAbout Radionetics Radionetics Oncology, Inc. is a clinical stage company focused on the discovery and development of novel radiopharmaceuticals for the treatment of a wide range of oncology indications and is poised to capitalize on the increasing demand for novel radiotherapeutics...

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical...

Minimum 8 years of experience in Regulatory Affairs, of which a minimum of 5 years must be in IVD Regulatory Affairs. Within the Regulatory Affairs Team, the Regulatory Affairs Manager will be responsible for the following, under the direction of Department Leadership. For on-market products, the...

The Senior Regulatory Affairs Manager leads regulatory submissions for CorDx medical devices, including 510(k) and other FDA submissions. Masters degree in Regulatory Affairs, Life Sciences, Engineering, or related field; advanced degree preferred. Senior Regulatory Affairs Manager.

The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. Perform regulatory assessments for product...

Prepare robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectives. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society. Anticipate regulatory obstacles and emerging issues throughout the prod...

Seeking a detail-oriented (preferably experienced) Regulatory Affairs Senior Specialist to join our regulatory department. Work closely with hospital administration, clinical departments, and external regulatory agencies to develop, implement and monitor compliance initiatives, policies, and proc...

Candidates should never be submitted directly to our hiring managers or employees. The Regulatory Affairs Operations Manager is responsible for publishing, QC, and transmittal of eCTD submissions.