Regulatory Affairs Manager Huisong PharmaceuticalsRegulatory Affairs ManagerSanta Ana, California$38–$48Position Overview Huisong Inc. is seeking an experienced Regulatory Affairs Manager to support regulatory strategy and compliance for dietary supplements, botanical ingredients, herbal extracts, and Traditional Chinese Medicine products. Founded in 1998, Huisong Pharmaceuticals specializes in the research, development, and manufacturing of premium-quality natural ingredients for leading companies in the pharmaceutical, nutraceutical, food and beverage, and personal care industries.
Regulatory Affairs Manager - Oncology and Regulatory Promotion Amgen IncRegulatory Affairs Manager - Oncology and Regulatory PromotionThousand Oaks, CAIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.
Regulatory Affairs Manager - IVD CorDxRegulatory Affairs Manager - IVDSan Diego, CAThe Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic products, including FDA 510(k), CLIA categorization/waiver activities, and other applicable regulatory pathways. CorDx Inc. is seeking an experienced Regulatory Affairs Manager to support the development, registration, and lifecycle management of in vitro diagnostic (IVD) medical devices in the United States.
NewBilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA Compliance Macpower Digital Assets Edge Private LimitedBilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA ComplianceLos Angeles, CA$90,000–$140,000 / yearGuided by the core values of Beautiful, Healthy, and Refreshing , they innovate beyond traditional cosmetics and household products, delivering creative solutions tailored to evolving consumer needs. As the Senior Regulatory Affairs Manager , you will ensure regulatory compliance for cosmetic, OTC, dietary supplement, and medical device products in North America—from concept to market launch.
Regulatory Affairs Manager Gateway RecruitingRegulatory Affairs ManagerSan Jose, CAThe candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas.
Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking) CorDxRegulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)San Diego, CAWith over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances.
Regulatory Affairs Manager - APAC - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Manager - APAC - Diabetes Care (on-site)Alameda, CA$114,000–$228,000 / yearYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager - APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
Regulatory Affairs Manager – APAC - Diabetes Care (on-site) AbbottRegulatory Affairs Manager – APAC - Diabetes Care (on-site)Alameda, CaliforniaYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
Senior Regulatory Affairs Manager - Digital Solutions (on-site) Abbott LaboratoriesSenior Regulatory Affairs Manager - Digital Solutions (on-site)Santa Clara, CA$130,700–$261,300 / yearSupporting pre-market and post-market cross functional teams; developing and communicating global regulatory strategies for new product submissions or complex changes to on-market products. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Senior Regulatory Affairs Manager (Onsite) CorDxSenior Regulatory Affairs Manager (Onsite)San Diego, CAWith over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and submissions.
Associate Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking) CorDxAssociate Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)San Diego, CAWith over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. The Associate Manager will work cross-functionally with internal teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle.
Compliance Manager, Licensing & Regulatory Affairs Felix TechnologiesCompliance Manager, Licensing & Regulatory AffairsSan Francisco, California$160,000–$210,000 / yearWe are a hyper-growth Series C company, backed by over $300 million in funding from top-tier global investors, including Andreessen Horowitz, QED, Castle Island, Switch Ventures, HTwenty, Monashees, General Catalyst Customer Value Fund. This individual will own the day-to-day management of Felix’s licensing portfolio, support expansion into new jurisdictions and products, and serve as the primary coordinator for regulator communications, examinations, and licensing-related projects.
Regulatory Affairs Manager – Diabetes Care (on-site) AbbottRegulatory Affairs Manager – Diabetes Care (on-site)Alameda, California$114,000–$228,000 / yearAs a member of the U.S. Regulatory Affairs management team, the successful candidate will lead and develop talent, shape regulatory strategy, and partner across functions to bring innovative products to market, whilst driving regulatory excellence for the manufacture, change management, and ongoing supply of the Libre portfolio. Drive and provide strategic guidance on FDA pathways, submissions, and interactions, including pre-submissions, 510(k), PMA, and post-market activities.
Sr. Regulatory Affairs Manager NeuroPace IncSr. Regulatory Affairs ManagerMountain View, CA$160,000–$190,000 / yearApplies Total Product Lifecycle (TPLC) and Quality System principles across the product lifecycle, exercising sound generalist judgment to identify emerging risks and issues, and knowing when and which subject matter expert (e.g., clinical, biocompatibility, software/cybersecurity, human factors, sterilization) to engage for deeper technical input. Generally, maintains a broad, working knowledge across TPLC and Quality System domains (design controls, risk management, post-market surveillance, CAPA) sufficient to identify issues early and route them to the appropriate subject matter expert.
Sr. Regulatory Affairs Manager NeuroPaceSr. Regulatory Affairs ManagerMountain View, CA$160,000–$190,000 / yearApplies Total Product Lifecycle (TPLC) and Quality System principles across the product lifecycle, exercising sound generalist judgment to identify emerging risks and issues, and knowing when and which subject matter expert (e.g., clinical, biocompatibility, software/cybersecurity, human factors, sterilization) to engage for deeper technical input. Generally, maintains a broad, working knowledge across TPLC and Quality System domains (design controls, risk management, post-market surveillance, CAPA) sufficient to identify issues early and route them to the appropriate subject matter expert.
Regulatory Affairs Manager – Heart Failure (on-site) AbbottRegulatory Affairs Manager – Heart Failure (on-site)Pleasanton, California$114,000–$228,000 / yearAs an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Regulatory Affairs Manager - Vascular (on-site) Abbott LaboratoriesRegulatory Affairs Manager - Vascular (on-site)Santa Clara, CA$114,000–$228,000 / yearThe candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
Manager, Regulatory Affairs Adicet Bio, Inc.Manager, Regulatory AffairsRedwood City, CAThey will be primarily responsible for managing the global CMC regulatory implementation of assigned projects in early to late-stage development, with additional responsibility to support the implementation of other regulatory activities, including clinical and nonclinical submissions. Assist senior RA staff in the development of Meeting Requests, Briefing Books and meeting materials for FDA and ex-US regulatory agency meetings, including pre-IND meetings, End of Phase meetings, Scientific Advice, etc.
Senior Manager Regulatory Affairs Workforce Solutions Virens GlobalSenior Manager Regulatory AffairsLos Angeles, CaliforniaA well-known large consumer products corporation is hiring for Regulatory Affairs Manager. Responsibilities include: Ensure completion of appropriate documents during the development life cycle and launch .
Senior Manager Regulatory Affairs - Systems & Software F. Hoffmann-La Roche LtdSenior Manager Regulatory Affairs - Systems & SoftwareCarlsbad, CA$126,800–$235,000 / yearYou will have the opportunity to navigate complex and evolving regulatory areas-including integrated instrument systems, software, cybersecurity, automation, connectivity, and digital technologies-while helping translate innovation into regulatory strategies that enable successful product development and commercialization. This role offers significant visibility, autonomy, and opportunity to influence, making it ideal for an experienced regulatory professional who enjoys solving complex problems, shaping strategy, and seeing their work directly contribute to the future of pathology and patient care.