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    Regulatory Specialist - New York, United States - GForce Life Sciences

    GForce Life Sciences
    GForce Life Sciences New York, United States

    4 weeks ago

    GForce Life Sciences background
    Description
    Regulatory Affairs Specialist II – On-site in Alameda, CA

    Qualifications
    BS in Life Sciences or Medical Engineering/Technology
    5+ years of professional experience (not internship experience)
    Medical device experience required
    Needs to have the skill set and able to hit the ground running
    Must be local candidates and 100% onsite

    Top Skills
    Risk management
    Product management
    Product registrations
    Impact assessment knowledge
    Chinese or Japanese bilingual preferred

    Day-to-Day Duties
    Implement and maintain the effectiveness of the quality system
    Support manufacturing/operations day-to-day activities for change control
    Provide consultation/advice to regulatory specialist for change control and product development
    Provide regulatory direction/interpretation on team activities
    Interpret and apply regulatory understanding to support products and teams
    Prepare U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide
    Handle regulatory activities involved in documentation, labeling, and field support
    Apply regulatory and technical knowledge to a wide variety of complex work assignments

    Term & Start
    1-year contract starting ASAP

    Pay Rate:
    Up to $60/hr ($120k annually)
    On-site in Alameda, CA

    Business Unit:
    Diabetes

    FT hours, 8a-5p; occasional night calls between 4-5p, 5-6p, or 6-7p
    Interview process: 1 or 2 Teams interviews
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