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    Regulatory Affairs Associate - Chicago, United States - INTELLECTT INC

    INTELLECTT INC
    INTELLECTT INC Chicago, United States

    1 week ago

    Intellectt Inc background
    Description
    Role: Regulatory Affairs Associate

    Location: Abbott Park, Illinois

    Duration: 8 Months on W2

    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.
    • 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 08830

    Email:

    Linked in :
    #J-18808-Ljbffr
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