Hippocratic AI builds the safest generative AI healthcare agent for health systems, payors, and pharma. Over 180 million clinical interactions across 1,000+ use cases with 60+ partners worldwide. Backed by General Catalyst, Kleiner Perkins and a16z.
About the role
The Head of Regulatory Affairs and Quality Control (RA/QC) is responsible for leading and executing global and domestic regulatory strategy, filings, and compliance activities for AI-driven SaMD products. This role requires a practitioner who not only knows FDA culture and regulatory frameworks, but can also operationalize them, drafting documents, building processes, and coordinating cross-functional activities.
What they're looking for
- 8+ years of regulatory affairs experience spanning medical devices, and digital health, related FDA-regulated products
- Bachelor’s degree in life science required
- Experience working at the FDA or directly interfacing extensively with FDA. Strong experience with FDA regulations and regulatory landscape
- Strong understanding of industry, including clinical trials, drug and device development, patient support services, ad/promo, pharmacovigilance, and post-market activities
- Demonstrated experience preparing and submitting INDs, NDAs/BLAs, 510(k)s, De Novos, PMAs, supplements, and/or Q-subs
- Strong experience with drug, device, and SaMD development, submissions, and regulatory pathways
More about this role
The Head of Regulatory Affairs and Quality Control (RA/QC) is responsible for leading and executing global and domestic regulatory strategy, filings, and compliance activities for AI-driven SaMD products. This role requires a practitioner who not only knows FDA culture and regulatory frameworks, but can also operationalize them, drafting documents, building processes, and coordinating cross-functional activities. Successful candidates will be able to interface with our customer’s regulatory leads to ensure alignment and successful deployment of our AI in the pharma and medtech space. This role reports to the VP of Strategy and will work closely with our , , clinical, and engineering, and LLM model teams.
Regulatory Strategy & Execution
Help develop and support regulatory strategies and submissions for AI-enabled SaMD products, including classification, marketing applications (e.g., NDAs, De Novo, 510(k)), and pre-submission pathways.
Help develop and support regulatory documentation that enables our customers in the pharma and medtech space to meet their compliance obligations when using Hippocratic AI’s products.
Lead hands-on preparation of regulatory submissions with Legal:...
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