# Head of Regulator Affairs & Quality Control at Hippocratic AI

- Company: Hippocratic AI
- What the company does: 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.
- Company website: https://www.hippocraticai.com/
- Type: Startups (AI role)
- Level: Principal and up
- Location: Menlo Park
- Work setup: On-site
- Posted: 2026-08-27
- Apply by: 2026-10-11
- Apply: https://jobs.ashbyhq.com/hippocratic%20ai/3b0f1de3-2517-4915-b82a-21c392c1dbd0
- Page: https://www.1752.vc/careers/jobs/hippocratic-ai-head-of-regulator-affairs-and-quality-control/

## 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

Tags: Corporate