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    Regulatory Affairs Manager - Bedford, United States - Genabio Diagnostics

    Genabio Diagnostics
    Genabio Diagnostics Bedford, United States

    3 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    Qualifications:

    • degree or above in a relevant discipline required
    • years of industrial experience in IVD or medical device FDA registration
    • in Chinese preferred

    Tasks:

    • and support new product 510k Submissions
    • and support International Device Licensing and Registrations
    • product development teams with new product submission requirements
    • guidance on worldwide regulatory requirements for medical devices and external government product audits by FDA and other inspection agencies as needed
    • and support the implementation of clinical research projects
    • and support clinical sites management through all phases of the clinical trial
    • to clinical sites during the qualification phase and as needed to ensure sites are in compliance and regulatory and study requirements are being fulfilled
    • that documentation from clinical trial sites meets FDA/GCP/GDP requirements


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