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Head of Regulatory Affairs & Quality Control

Hippocratic AI· G&A
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Menlo Park, CAFull-timePosted 1mo ago

About the role

Lead and execute global and domestic regulatory strategy, filings, and compliance activities for AI-driven SaMD products; interface with customers’ regulatory leads; report to the VP of Strategy; collaborate across clinical, engineering, and LLM model teams.

Responsibilities

  • 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.
  • Regulatory Strategy & Execution - 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.
  • Regulatory Strategy & Execution - Lead hands-on preparation of regulatory submissions with Legal: drafting sections, coordinating data inputs, managing timelines, and ensuring high-quality documentation.
  • Regulatory Strategy & Execution - Translate regulatory requirements into specific, actionable tasks for clinical, product, engineering, and quality teams.
  • Regulatory Strategy & Execution - Oversee and advance global and domestic regulatory and compliance initiatives, maintaining scientific accuracy, proactively managing risk, and keeping the organization aligned with changing regulatory expectations.

Qualifications

  • 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.
  • Familiarity with AI-enabled medical technologies, machine learning considerations, and evolving FDA expectations for AI/ML.
  • Demonstrated ability to thrive in fast-paced, dynamic startup environments with limited structure and high ownership.
  • Excellent written and verbal communication skills, especially for FDA submissions and internal education.

Skills

Required:Regulatory strategyRegulatory submissions (INDs/NDAs/510(k)/De Novo)FDA interfacing
Last updated Sep 30, 2026. Interested? Apply on the company site.

About Hippocratic AI

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