Digital Health FDA Consultant - Boston - Saviance

    Saviance
    Saviance Boston

    1 day ago

    Description

    Job Title: Digital Health FDA Consultant

    We are seeking an experienced Digital Health FDA Consultant with deep expertise in Software as a Medical Device (SaMD) and hands-on experience guiding AI-driven products through the FDA clearance process.

    About the Role

    • Provide end-to-end regulatory guidance for FDA SaMD submissions, including 510(k), De Novo, Pre-Sub, etc.
    1. Develop and review documentation:

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