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    Regulatory Affairs Specialist - Washington, United States - CM Medical Recruitment

    CM Medical Recruitment
    CM Medical Recruitment Washington, United States

    3 weeks ago

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    Description

    CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space.

    In this critical role, you will be responsible for developing and executing regulatory strategies to drive the successful commercialization of products across global markets.

    Key Responsibilities:

    Develop, lead, and manage regulatory functions to ensure compliance with global regulations, including FDA, EU, and country-specific requirements.

    Prepare robust regulatory submissions, coordinate with cross-functional teams, and manage submission processes for products across multiple geographies.

    Requirements:

    4+ years of regulatory affairs experience in medical devices, preferably with Class III and AIMD devices.

    Proven expertise in authoring regulatory submissions (PMA, IDE, Technical Files, Registrations, etc.).

    Proficiency in ISO 13485, IEC , ISO 14971, IEC 62304, EU MDR, 21 CFR 820, and other

    In-depth knowledge of US, EU, and international medical device regulations.

    Experience with medical device hardware, software, and quality system requirements.

    To be considered for this position, please apply directly or email with your resume and availability for a call.

    Please note; I anticipate a lot of applicants and I'm simply unable to respond to all. If you do not meet the above criteria and haven't heard from me within 14 days of applying, please assume you have been unsuccessful.

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