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    Regulatory Affairs Associate - Alameda, United States - INTELLECTT INC

    INTELLECTT INC
    INTELLECTT INC Alameda, United States

    4 weeks ago

    Intellectt Inc background
    Description
    Hello,

    I Hope you are doing great.

    This is Bhanu from Intellectt INC; weve got an important role Regulatory Affairs Associate -Alameda, CA with one of our prestigious clients. Interested candidates can please send your updated resume at

    Role: Regulatory Affairs Associate

    Location: Alameda, CA

    Duration: 12 Months

    Shift Timings: 8 AM to 5 PM PST

    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,

    Ajay Bhanu

    Intellectt Inc

    Direct:

    Desk number : Ext: 159

    517 Route 1 South, Suite 1115 Iselin, NJ 08830

    WhatsApp:
    #J-18808-Ljbffr
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