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    Regulatory Affairs Specialist - Santa Clara, United States - INTELLECTT INC

    Intellectt Inc background
    Description
    Hello,

    Hope you are doing well.

    This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to or call me at


    Role:
    Regulatory Specialist II


    Location:
    Santa Clara, CA

    Duration:

    12 Months

    Shift Timings:

    8am to 5pm

    Responsibilities

    Implement and maintain the effectiveness of the quality system.
    Support day-to-day manufacturing/operations activities for change control.
    Provide consultation/advice for regulatory specialists on change control and product development.
    Offer regulatory direction/interpretation for team activities.
    Prepare U.S. regulatory submissions and registration documents for international affiliates.
    Handle regulatory activities related to documentation, labeling, and field support.
    Apply regulatory and technical knowledge to complex work assignments.
    Ensure compliance with the appropriate quality system and site/division level policies and procedures.

    Requirements

    Bachelor's degree preferred in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
    2-5 years of regulatory experience and/or 2 years of relevant industrial experience.
    Knowledge of regulations and standards affecting IVDs and/or biologics.
    Working knowledge of EU MDR and Regulatory Change Assessment.
    Experience with US and EU medical device submissions.

    #J-18808-Ljbffr


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