• Quality Systems & Regulatory Staff…

    BD (Becton, Dickinson and Company) (San Diego, CA)
    …for decision-making. Additionally, it manages regulatory communications such as FDA responses, drives continuous improvement across the quality system, and ... **Job Description Summary** The Quality Systems and Regulatory Staff Lead...FDA warning letters, field action inquiries, and other regulatory correspondence. Ensure timely and accurate updates on mitigation… more
    BD (Becton, Dickinson and Company) (12/24/25)
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  • Vice President, Regulatory Affairs…

    Sumitomo Pharma (Sacramento, CA)
    …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... the quality and scientific integrity of documents submitted to regulatory authorities + In collaboration with Commercial, Medical and Legal colleagues, conduct… more
    Sumitomo Pharma (12/23/25)
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  • Regulatory Specialist

    Actalent (Fresno, CA)
    …all regulatory export documentation (Certificates of Free Sale, Health and Quality Certs, Declarations) Monitor regulatory changes and assess potential risks ... management of technical requests for all health care products. Develop regulatory documentation related to ingredients, formulations, and labels and ensure… more
    Actalent (01/10/26)
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  • Regulatory Affairs Specialist 3 - Medical…

    Grifols Shared Services North America, Inc (San Diego, CA)
    …**Primary responsibilities for role:** + Prepares and files complex pre-market and post-market regulatory submissions with the US FDA , Notified Bodies in the EU ... in reducing regulatory risk. + Review, provide regulatory input to, and approve various quality ...solutions to management + Demonstrated ability to communicate with FDA and international customers (eg, regulatory agencies,… more
    Grifols Shared Services North America, Inc (12/17/25)
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  • Director, Regulatory Affairs…

    Stryker (Sacramento, CA)
    …development including global regulatory strategy, submissions, approvals, and regulatory and quality compliance. **Essential Duties and Responsibilities:** + ... for commercial drug product disposition and release in addition to Quality Assurance responsibilities.Viewed as pharmaceutical regulatory expert within business.… more
    Stryker (01/13/26)
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  • Regulatory Affairs Associate Director, IVD

    GRAIL (Menlo Park, CA)
    …Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and ... Quality , Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market… more
    GRAIL (12/03/25)
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  • Senior Manager, Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Sacramento, CA)
    **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
    Otsuka America Pharmaceutical Inc. (11/20/25)
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  • Sr. Manager, Regulatory Affairs Cell…

    ThermoFisher Scientific (Carlsbad, CA)
    …claims. + Author and/or review regulatory submissions, specifically device master files, regulatory support files, and meeting requests to FDA and other ... experience strongly preferred. **Knowledge, Skills, Abilities:** + Extensive knowledge of regulatory requirements, including those from the FDA , Health Canada,… more
    ThermoFisher Scientific (01/14/26)
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  • Associate Principal, Regulatory Affairs

    Terumo Neuro (Aliso Viejo, CA)
    …approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and ... **12814BR** **Title:** Associate Principal, Regulatory Affairs **Job Description:** Responsible for establishing and...+ Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as… more
    Terumo Neuro (01/07/26)
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  • Principal, Regulatory Affairs

    Terumo Neuro (Aliso Viejo, CA)
    …for submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and ... **13011BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for establishing, preparing,...+ Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as… more
    Terumo Neuro (12/16/25)
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