• Senior Manager Regulatory Affairs - Global…

    Abbott (Santa Clara, CA)
    …legislation, regulations, and guidances + Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA + Utilizes technical ... Abbott is a global healthcare leader that helps people live more fully...and maintenance in regulated environments. + In-depth knowledge of regulatory frameworks (eg, FDA , EMA, ISO 13485,… more
    Abbott (08/08/25)
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  • Executive Director, US Regulatory…

    BeOne Medicines (San Mateo, CA)
    …**Essential Functions of the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically ... and advice on FDA interactions. + Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission… more
    BeOne Medicines (07/27/25)
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  • Staff Specialist Regulatory Affairs…

    BD (Becton, Dickinson and Company) (San Diego, CA)
    …execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents. + Provide regulatory input during the ... Guidance and SaMD related Guidance. + Knowledge of international regulatory requirements (eg, FDA QSR, ISO 13485,...and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum… more
    BD (Becton, Dickinson and Company) (05/22/25)
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  • Regulatory Affairs Specialist II - Ventures…

    Abbott (Santa Clara, CA)
    …trial operations and product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory ... Abbott is a global healthcare leader that helps people live more fully...communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA… more
    Abbott (05/17/25)
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  • Regulatory Affairs Manager - International…

    Abbott (Alameda, CA)
    …on future actions. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies, ... Abbott is a global healthcare leader that helps people live more fully...levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will work… more
    Abbott (06/21/25)
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  • Senior Manager, Regulatory Operations

    Sumitomo Pharma (Sacramento, CA)
    …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory … more
    Sumitomo Pharma (07/18/25)
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  • Director, Regulatory Advertising…

    Sumitomo Pharma (Sacramento, CA)
    …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
    Sumitomo Pharma (07/08/25)
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  • Sr. Manager, Regulatory Compliance…

    J&J Family of Companies (Santa Clara, CA)
    … regulatory requirements in the light of current guidance and FDA /International regulatory body field activity. **REQUIRED KNOWLEDGE, SKILLS, ABILITIES, ... Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where...Johnson & Johnson is hiring for a **Sr. Manager, Regulatory Compliance - Shockwave Medical** to join our team… more
    J&J Family of Companies (07/30/25)
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  • Associate Director Regulatory Affairs

    Abbott (San Diego, CA)
    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... healthcare , with leading businesses and products in diagnostics, medical...executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs** , works out of our **San Diego,… more
    Abbott (07/10/25)
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  • Senior Manager, Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Sacramento, CA)
    …(eg, clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
    Otsuka America Pharmaceutical Inc. (06/19/25)
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