• Senior Regulatory Affairs…

    Medtronic (Irvine, CA)
    …reports, and ensuring that our product technical documentation is current and accurate. ** SENIOR REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR** In the ... 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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  • Senior Regulatory Affairs…

    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…

    Actalent (Valencia, CA)
    Senior Regulatory Affairs Specialist Job Description As a Senior Regulatory Affairs Specialist , you will be responsible for planning, ... coordinating, compiling, drafting, and filing US and EU regulatory submissions . Your role is to ensure that all submissions are accurate, high quality, and… more
    Actalent (07/16/25)
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  • Senior Regulatory Specialist

    Globus Medical, Inc. (Audubon, PA)
    …can 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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  • Senior Specialist

    West Pharmaceutical Services (Exton, PA)
    Senior Specialist , Regulatory Affairs...of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, ... including Premarket Notifications and Technical Documentation for CE Marking. The Senior Specialist ensures timely and high-quality execution of all… more
    West Pharmaceutical Services (05/14/25)
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  • Senior Regulatory Affairs…

    Medtronic (Minneapolis, MN)
    …cross-functional collaboration as we work together to engineer the extraordinary. The ** Senior Regulatory Affairs Specialist ** develops strategies for ... devices to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with… more
    Medtronic (07/12/25)
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  • Senior Regulatory Affairs…

    Abbott (Santa Clara, CA)
    …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This ** Senior Regulatory Affairs Specialist ** position is an onsite ... Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is...for submission filing. + Compile, prepare, review and submit regulatory submissions to authorities. + Monitor impact… more
    Abbott (06/20/25)
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  • Senior Regulatory Affairs…

    Cook Medical (Bloomington, IN)
    Overview The Senior Regulatory Affairs Specialist responsible for the planning and preparation of submissions to obtain regulatory approvals for new ... III and IV medical devices in specific markets. In addition to submissions , the Regulatory Affairs Specialist will serve as a communication liaison between… more
    Cook Medical (07/16/25)
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  • Senior Regulatory Affairs…

    Stryker (Weston, FL)
    We are seeking a ** Senior Regulatory Specialist ** to join our Mako and Enabling Technology business within the Joint Replacement Division to be based hybrid ... or Weston, FL. **What you will do** As the ** Senior Regulatory Affairs Specialist ** ,...divisions. You will participate in cross-functional teams, develop global regulatory strategies, author regulatory submissions ,… more
    Stryker (06/01/25)
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  • Senior Regulatory Affairs…

    Abbott (Alameda, CA)
    …you help Abbott shape the future of healthcare. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and ... medical devices . Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance . Prepares robust … more
    Abbott (06/11/25)
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