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    Regulatory Affairs Associate - Alameda, United States - GForce Life Sciences

    GForce Life Sciences background
    Description
    Regulatory Affairs Associate - On-site in Alameda, CA
    Term & Start
    1-year contract with possibility to extend, starting ASAP
    On-site in Alameda, CA

    Pay Rate:
    Up to $40-48/hr based on experience ($80-96k)
    FT hours, M-F 8a-5p

    Business Unit:
    Diabetes Care

    Interview Process: 1 interview with hiring manager and then interview with manager's leadership

    Summary

    This role would work in the Emerging Regulations team of the Diabetes Care Division, managing narrow and specific regulations with cross-functional teams.

    The ideal candidate will have strong analytical skills, proactive communication skills, and strong organizational and documentation skills.

    Day-to-Day Duties
    Identify gaps in processes or product design (documentation)
    File necessary applications and handle all government interactions regarding the regulation process for products requiring governmental approval
    Review/approve engineering study protocols/reports and validation study protocols/reports
    Review and assess emerging regulations

    Qualifications
    Recent experience with medical device design controls ideal
    Understanding of engineering change control process
    Familiarity with Agile PLM system
    May require an advanced degree and 2-4 years of direct experience in the field
    Relies on analytical thinking and judgment to plan and accomplish goals
    A wide degree of creativity and latitude is expected
    Open to Engineering, Quality, or Manufacturing backgrounds who are interested in a career in Regulatory Affairs

    #J-18808-Ljbffr


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