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    Regulatory Affairs Manager - Chicago, United States - Catalyst Life Sciences

    Catalyst Life Sciences
    Catalyst Life Sciences Chicago, United States

    5 days ago

    Default job background
    Description

    Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existing and new product submissions to the FDA and Canada. Leading a small team, this is for somebody with prior Regulatory management experience and knowledge of IVD requirements.

    Main Responsibilities

    • Lead the US & Canada Regulatory team to prepare the documentation and submissions for FDA and Health Canada, as well as the responses to regulatory agencies.
    • Manage the maintenance of device registrations and ongoing compliance activities.
    • Responsible for the ongoing reviewing of regulatory materials for accuracy, comprehensiveness, and compliance with regulatory standards.

    Experience Required

    • 6 years' Regulatory Affairs experience within Medical Devices or IVDs, understanding FDA requirements for 510(k)s and 21 CFR 820.
    • Prior management or team leadership experience.
    • Experience working directly with regulatory agency representatives.
    • This is a hybrid role that requires at least 3 days a week onsite in Chicago, IL.
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