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    Regulatory Specialist II - Santa Clara, United States - The Fountain Group

    The Fountain Group
    The Fountain Group Santa Clara, United States

    3 weeks ago

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    Description


    Hello,This is ShivaRaj from The Fountain Group, we are currently seeking a Regulatory Specialist II for a prominent client of ours.

    This position is located in Santa Clara, CA.

    Details for the position are as follows:

    Pay:
    $60-56Experience:2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairsSkills:Knowledge of regulations and standards affecting IVDs and/or biologics/Medical deviceEducation:BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc

    Duties:
    Responsible for implementing and maintaining the effectiveness of the quality system.
    Supports manufacturing/operations day to day activities for change control.
    Provides consultation/advice to regulatory specialist for change control and product development.
    Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams.
    Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
    Handles regulatory activities involved in documentation,labeling,field support.
    Applies regulatory and technical knowledge to a wide variety of complex work assignments.

    Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.

    Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.#J-18808-Ljbffr
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