• Clinical Research Coordinator A/B

    University of Pennsylvania (Philadelphia, PA)
    …such as: Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions . Communicate with study team members. ... submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Our projects occur throughout the… more
    University of Pennsylvania (07/11/25)
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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...a very timely and accurate manner. **_Sr Reg Affairs Specialist I_** **Primary responsibilities for role:** + Act as… more
    Grifols Shared Services North America, Inc (05/14/25)
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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 ... compassionate world. **A Day in the Life** The Sr Regulatory Affairs Specialist will play a key...the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities… more
    Medtronic (06/10/25)
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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 ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting...PMA submissions a plus + Experience assessing regulatory more
    Globus Medical, Inc. (06/25/25)
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  • Regulatory Affairs Specialist 4

    Hologic (Newark, DE)
    Specialist 4 performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and ... Regulatory Affairs Specialist 4 Newark, DE,...the international regulatory affairs group to support regulatory submissions worldwide for medical devices and… more
    Hologic (07/12/25)
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  • Sr. Regulatory Affairs Specialist

    Caldera Medical (Westlake Village, CA)
    Senior Regulatory Specialist Located in Westlake Village, CA; Onsite - No remote option. Caldera Medical's Mission - To Improve the Quality of Life for Women! In ... your role as a Sr. Regulatory specialist , you will develop and implement...worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on… more
    Caldera Medical (06/04/25)
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  • Sr. Regulatory Affairs Specialist

    Medtronic (Minneapolis, MN)
    …+ Experience working in regulated, biotechnology environment, including involvement with regulatory submissions , interactions with regulatory agencies (eg, ... a more connected, compassionate world. **A Day in the Life** **SENIOR REGULATORY AFFAIRS SPECIALIST ** In collaboration with leading clinicians, researchers and… more
    Medtronic (07/02/25)
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  • Regulatory Affairs Specialist

    BD (Becton, Dickinson and Company) (Covington, GA)
    … Affairs Specialist I is responsible for implementation of regulatory strategies including domestic and international submissions and other support ... **Job Description Summary** Regulatory Affairs Specialist I, Hybrid -... Specialist I are responsible for implementation of regulatory strategies including domestic and international submissions more
    BD (Becton, Dickinson and Company) (07/02/25)
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  • Senior Regulatory Specialist

    Globus Medical, Inc. (Audubon, PA)
    …resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... submissions , and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
    Globus Medical, Inc. (06/25/25)
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  • Principal Regulatory Affairs…

    Medtronic (Minneapolis, MN)
    …to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with ... + Experience working in regulated, biotechnology environment, including involvement with regulatory submissions , interactions with regulatory agencies (eg,… more
    Medtronic (07/17/25)
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