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    Senior Regulatory Affairs Specialist - Los Angeles, United States - Barrington James

    Barrington James
    Barrington James Los Angeles, United States

    1 week ago

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    Description
    Senior Regulatory Affairs Specialist (Medical Devices) - Hybrid (Bay Area)

    Our client is a growing Imaging Medical Device company that is making a meaningful impact on patient lives. They are looking for a Senior Regulatory Affairs Specialist with a track record of bringing imaging devices to market.


    Responsibilities:
    Prepare and submit regulatory submissions, including 510(k) and MDR, to ensure compliance and support product commercialization.
    Collaborate with cross-functional teams to develop and implement robust regulatory strategies.
    Maintain clearances and approvals, ensuring compliance with FDA regulations and European medical device regulations.
    Manage multiple projects simultaneously, prioritizing tasks and meeting critical deadlines.
    Provide advice throughout entire product lifecycle from concept through to post market.
    Support internal and external audits.

    Requirements:
    Proven experience in Regulatory Affairs within the medical device industry, with expertise in 510(k) submissions and MDR compliance.
    In-depth knowledge of FDA regulations, including Quality standards and regulations including ISO 13485, MDSAP and 21 CFR 820.
    Ability to thrive in a fast-paced, dynamic environment, managing multiple projects efficiently.
    Excellent attention to detail and strong organizational skills.
    Effective communication and collaboration skills to work with cross-functional teams.
    Results-oriented mindset and proactive problem-solving abilities.

    If you would like to learn more about this Senior Regulatory Affairs Specialist opportunity, apply today or contact me directly:

    #J-18808-Ljbffr
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