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    Regulatory Affairs Associate - Chicago, United States - PSG Global Solutions

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    Description
    We're looking for a

    Regulatory Affairs Associate , working in

    Biotechnology/Medical Devices

    industry in

    100 Abbott Park Road, Lake Forest, Illinois, 60064, United States .


    Job description:


    Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.

    Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
    Review/approval of engineering study protocols/reports and validation study protocols/reports.
    Review and approval of manufacturing changes for Class III implantable medical devices.

    #J-18808-Ljbffr


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