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    Vice President Regulatory Affairs - Los Angeles, United States - Barrington James

    Barrington James
    Barrington James Los Angeles, United States

    3 weeks ago

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    Description
    Vice President Regulatory Affairs (Medical Device) - ONSITE in Bay Area

    Our esteemed client, a inovative and growing medical device company specializing in the manufacturing of implantable medical devices.

    They are looking for a Vice President Regulatory Affairs to spearhead regulatory strategies that will shape the future of healthcare and continue building out their Regulatory Department.


    Key Responsibilities:


    Develop and implement global regulatory strategies for the successful approval and commercialization of implantable devices in the US and international markets.

    Oversee the preparation and submission of regulatory dossiers for FDA and OUS regulatory approvals, including IDE, 510(k), PMA, and CE Mark applications.

    Act as the primary point of contact with regulatory authorities, ensuring open communication and successful interactions during the review process.

    Collaborate cross-functionally with R&D, Quality Assurance, Clinical Affairs, and other departments to align regulatory objectives with business goals.

    Stay abreast of evolving regulatory requirements and industry trends, providing guidance to the executive team and ensuring the company's ongoing compliance with global regulations.

    Experience with implantable devices and Software experience/Cybersecurity would be a plus.
    Build and develop a proactive, versatile and cross functional regulatory team.


    Qualifications:
    A minimum of 12 years of experience in regulatory affairs within the medical device industry.

    Proven track record of successful regulatory submissions and approvals in both the US (510k, De Novo, PMA) and international markets (CE Mark and OUS submissions).

    Strong leadership and management skills, with experience leading regulatory teams and driving results in a fast-paced environment.
    Deep knowledge of the full product lifecycle for Medical Devices.
    In-depth knowledge of global medical device regulations, standards, and guidelines, and the ability to interpret and apply them effectively.
    Excellent communication and interpersonal skills, with the ability to build relationships with regulatory authorities and cross-functional teams.
    A bachelor's degree in a related field (Engineering); an advanced degree is preferred.

    If you would like to learn more about this Vice President Regulatory Affairs opportunity and have the desire to build and develop a regulatory team, apply today or contact me directly on the following:

    #J-18808-Ljbffr
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