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    Regulatory Specialist II - Scarborough, United States - The Fountain Group

    The Fountain Group
    The Fountain Group Scarborough, 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 Scarborough, ME. Details for the position are as follows:

    Pay: $47-$56

    Experience:
    2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function

    Skills:
    Knowledge of regulations and standards affecting IVDs and/or biologics

    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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