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

    The Fountain Group
    The Fountain Group Santa Clara, United States

    4 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: $60-56

    Experience:

    • 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs
    Skills:
    • Knowledge of regulations and standards affecting IVDs and/or biologics/Medical device
    Education:
    • 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.
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