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    Regulatory Affairs Specialist - Santa Clara, United States - GForce Life Sciences

    GForce Life Sciences
    GForce Life Sciences Santa Clara, United States

    Found in: Appcast US C2 - 1 week ago

    GForce Life Sciences background
    Upper Management / Consulting
    Description

    Regulatory Affairs Specialist II Santa Clara, CA

    Must be able to work on a W2

    Job Summary

    We're looking for a Regulatory Specialist with 2-5 years of experience in the medical device industry. Your responsibilities include maintaining the quality system, supporting manufacturing operations, and providing regulatory guidance. Experience with international product registrations and electronic document control systems is a plus.

    Responsibilities:

    • 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, field support
    • Apply regulatory and technical knowledge to a wide variety of complex work assignments
    • Maintain and ensure compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports
    • Ensure compliance to and demonstrate knowledge of site and division level policies and procedures

    Qualifications:

    • 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function
    • Knowledge of regulations and standards affecting IVDs and/or biologics
    • BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
    • Experience with international (outside of EU and US) product registrations preferred
    • Experience working with medical device operations on control of product release preferred
    • Experience working with electronic change management/document control systems preferred

    Term & Start

    • 6- month contract
    • FT, M-F 40hr/week
    • Pay Rate: $50-55/HR K Annually)
    • Onsite in Santa Clara, CA
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