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Alameda

    Regulatory Specialist - Alameda, United States - GForce Life Sciences

    GForce Life Sciences
    GForce Life Sciences Alameda, United States

    2 weeks ago

    GForce Life Sciences background
    Description
    Regulatory Affairs Specialist II On-site in Alameda, CAQualificationsBS in Life Sciences or Medical Engineering/Technology5+ years of professional experience (not internship experience)

    Medical device experience requiredNeeds to have the skill set and able to hit the ground runningMust be local candidates and 100% onsiteTop SkillsRisk managementProduct managementProduct registrationsImpact assessment knowledgeChinese or Japanese bilingual preferredDay-to
    • Day DutiesImplement and maintain the effectiveness of the quality systemSupport manufacturing/operations day to day activities for change controlProvide consultation/advice to regulatory specialist for change control and product developmentProvide regulatory direction/interpretation on team activitiesInterpret and apply regulatory understanding to support products and teamsPrepare U.
    S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwideHandle regulatory activities involved in documentation, labeling, and field supportApply regulatory and technical knowledge to a wide variety of complex work assignmentsTerm & Start1-year contract starting ASAPPay Rate:
    Up to $60/hr ($120k annually)

    On-site in Alameda, CA Business Unit:
    DiabetesFT hours, 8a-5p; occasional night calls between 4-5p, 5-6p, or 6-7pInterview process: 1 or 2 Teams interviews#J-18808-Ljbffr
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