• Senior Manager Regulatory Affairs - Global…

    Abbott (Santa Clara, CA)
    …units that Leverage Services team supports, including the execution of strategic regulatory initiatives, regulatory submissions , agency relationship and ... leadership experience to support the medical device business units with their regulatory submissions . Collaborates closely with internal regulatory more
    Abbott (08/08/25)
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  • Senior Regulatory Affairs Specialist

    Grifols Shared Services North America, Inc (Clayton, NC)
    …products. + Prepare responses to regulatory agency inquiries. + Compile regulatory submissions through coordination with other departments and research of ... a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. This could include… more
    Grifols Shared Services North America, Inc (05/14/25)
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  • Senior Manager, Regulatory Operations

    Sumitomo Pharma (Lincoln, NE)
    …agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions . Guides and trains project teams on new requirements, ... of external publishing staff contracted to publish and dispatch health authority submissions . + Represents Regulatory Operations on project teams for matters… more
    Sumitomo Pharma (07/18/25)
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  • Regulatory Specialist

    Globus Medical, Inc. (Audubon, PA)
    …medical device development and registration of products + Demonstrated knowledge of US regulatory submissions ; Pre-Sub, and 510(k); working knowledge of IDE and ... PMA submissions a plus + Experience assessing regulatory impact of product/process changes + Experience reviewing labeling, promotional literature, etc. +… more
    Globus Medical, Inc. (06/25/25)
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  • Principal Regulatory Affairs Specialist

    Medtronic (Los Angeles, CA)
    …for new and modified Class IIa & Class III devices and preparing and submitting regulatory submissions in the EU and supporting outside of US (OUS) geographies. ... portfolio and regulatory and quality system procedures. + Prepare regulatory submissions for new products and product changes, as required, to ensure timely… more
    Medtronic (08/08/25)
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  • Director Global Regulatory Affairs

    Fresenius Medical Center (Waltham, MA)
    …pharmaceutical portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions . + Collaborate with senior leadership in ... and potential risks to inform decision-making across the organization. + **Global Regulatory Submissions :** + Oversee the planning, preparation, and execution of… more
    Fresenius Medical Center (06/14/25)
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  • Associate Director, Regulatory Affairs…

    AbbVie (Irvine, CA)
    …maintenance of chemistry, manufacturing, and controls (CMC) device sections of regulatory submissions , responses to Agency questions for worldwide registration ... care medicinal delivery products. Responsibilities: + Develops and prepares pre-market regulatory submissions . Demonstrated success in directly securing … more
    AbbVie (08/08/25)
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  • Regulatory Operations Senior Publisher…

    System One (Florham Park, NJ)
    … information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions . + Maintain knowledge of local regulatory ... DMF). + Ensure consistency across regulatory submission documents following the regulatory style guide (ie formatting, reviewing, and submissions ). + Provide… more
    System One (08/03/25)
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  • Senior Regulatory Affairs Specialist

    Medtronic (Irvine, CA)
    …partners with the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities include reviewing ... partners with the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities include reviewing… more
    Medtronic (07/29/25)
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  • Senior Manager, Regulatory Affairs CMC…

    AbbVie (Waltham, MA)
    …enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications ... + Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions , including new applications and amendments, renewals annual… more
    AbbVie (07/25/25)
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