Head of Regulatory Affairs for AI Health SaMD

Job description

Hippocratic AI is seeking a Head of Regulatory Affairs to lead global regulatory strategy, filings, and compliance for AI‑driven SaMD and pharma/medtech collaborations. This role interfaces with Legal, Clinical, Product, Engineering, and QA teams to translate requirements into actionable plans and ensure timely submissions.

You will build a pragmatic regulatory framework suited for a startup, maintain SOPs, and guide teams through FDA pathways such as NDAs, De Novo, 510(k), and PMAs, while

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Who can apply

Review the original listing for work authorization, qualifications and employer requirements.