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    Regulatory Affairs Specialist - Irvine, United States - Tucker Parker Smith Group (TPS Group)

    Tucker Parker Smith Group (TPS Group)
    Tucker Parker Smith Group (TPS Group) Irvine, United States

    2 weeks ago

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    Description

    Job Title: Regulatory Affairs Specialist

    Location: Irvine, CA

    Schedule: Hybrid, Monday to Friday, 8 AM to 5 PM, with on-site work Tue/Thur

    Duration: 1 year with potential to extend/ convert to internal FTE

    no fully remote option

    hourly rate of $40-45/hr

    About Us: We are seeking a Regulatory Affairs Specialist to join our team in Irvine, CA. Our company focuses on supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition activities for our biotech clients' products. This role offers a hybrid work schedule with opportunities to work closely with cross-functional teams.

    Responsibilities:

    • Support the transition of products from the IVD Directive to IVDR requirements, including technical file revisions and labeling updates.
    • Collaborate with cross-functional teams to ensure smooth labeling conversion and compliance with IVDR.
    • Monitor manufacturing schedules, track change requests, and update labeling tracking logs for accuracy.
    • Update IVDR Technical Files to the latest template and include all necessary attachments.

    Requirements:

    • Bachelor's degree in biochemistry, biology, medical technology, or related fields.
    • 3-5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management in the IVD industry.
    • Thorough knowledge of regulatory policies, practices, and procedures related to Regulatory Affairs.
    • Familiarity with FDA and CE marking requirements for IVD products is a plus.
    • Strong communication, negotiation, and persuasion skills.
    • Analytical, problem-solving, computer, and critical thinking abilities.
    • Ability to work independently and collaboratively with others.

    How to Apply: Please submit your resume in Word or PDF format for consideration.

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