Regulatory Affairs Specialist - Bound Brook - Spectrum Vascular

    Spectrum Vascular
    Spectrum Vascular Bound Brook

    1 day ago

    $70,000 - $120,000 (USD) per year *
    Description

    Regulatory Affairs Specialist

    Spectrum Vascular is an innovative medical device company focused on vascular access and medication management to improve patient lives worldwide. Our mission is to provide caregivers with high quality products, exceptional customer service and innovation.

    The Regulatory Affairs (RA) Specialist supports global regulatory submissions, ensuring medical devices meet applicable requirements throughout their lifecycle. This role collaborates cross-functionally with Quality, Engineering, Clinical and Manufacturing teams for filings like FDA 510(k), EU MDR Technical Documentation and Health Canada.

    Key responsibilities include preparing, formatting and compiling regulatory submissions; supporting maintenance of files; responding to requests for additional information; assisting in U.S. and EU market approval processes; providing regulatory assessments for changes or product transfers.

    The RA Specialist will also communicate with distributors about inquiries or filings support training initiatives related to compliance interpreting new regulations ensuring business practices align

    Bachelor's degree in a scientific area (RAC certification preferred),1-3 years experience in regulated environments strong understanding of FDA,EU medical device regulations proficiency PC systems office applications solid understanding scientific principles applied regulatory affairs Spectrum Vascular Equal Opportunity Employer creating diverse inclusive culture
    * This salary range is an estimation made by beBee
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