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    Regulatory Affairs - Chicago, United States - INTELLECTT INC

    Intellectt Inc background
    Description

    Role :

    Regulatory Affairs AssociateDuration : 8 MonthsJob Descriptionresponsible 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.
    May require an advanced degree and 5- 8 years of direct experience in the field.
    • Recent experience with Class III implantable medical devices.
    Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements. knowledge of FDA PMA guidance documents and CFR regulations.
    Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks.
    May lead and direct the work of others.
    • A wide degree of creativity and latitude is expected.
    Typically reports to a manager or head of a unit/department.Thanks & regards,Teja Recruiter | Intellectt Inc | Ph: Add: 517 Route 1 South, Suite 1115 Iselin, NJ 08830Email:

    comLinked in :


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  • INTELLECTT INC

    Regulatory Affairs

    3 weeks ago


    INTELLECTT INC Chicago, United States

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