Hippocratic AI · 1 month ago
Head of Regulatory Affairs
Palo Alto
Full-time
Onsite
Director/Executive
10+ years expHippocratic AI is the leading generative AI company in healthcare, focused on transforming patient outcomes through innovative technology. The Head of Regulatory Affairs will lead the global regulatory strategy and compliance for clinical trials and AI-driven products, ensuring alignment with FDA regulations and operationalizing regulatory frameworks across teams.
Artificial Intelligence (AI)Foundational AIGenerative AIHealth CareInformation Technology
Responsibilities
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: drafting sections, coordinating data inputs, managing timelines, and ensuring high-quality documentation
Translate regulatory requirements into specific, actionable tasks for clinical, product, engineering, and quality teams
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
Build, manage, and continuously improve a practical regulatory compliance structure across SaMD development lifecycles
Collaborate with legal, engineering, clinical, product, and quality teams to ensure compliance with applicable regulations, including 21 CFR Parts 210 and 211, 21 CFR Part 820, SaMD guidance, AI/ML-specific expectations and guidance, cybersecurity, and labeling requirements
Help design, support, and maintain a compliant regulatory framework and Pharma-partner guidelines, including iterative AI development, model updates, QMS and GMP requirements, audits and inspections, real-world performance, and post-market monitoring and mitigation
Develop and maintain SOPs, controlled documents, audit readiness materials, and inspection response processes
Stay ahead of evolving regulatory policies and draft internal guidance to translate new requirements into clear action for cross-functional teams
Interact with customer regulatory leads to facilitate deployment of Hippocratic’s solutions with customers in the pharma and medtech industry
Partner with legal, product, and engineering teams during development to define regulatory requirements early and de-risk product strategy
Educate technical and clinical teams on regulatory expectations, FDA and pharmaceutical industry norms, and quality documentation needs
Drive internal regulatory training and ensure that cross-functional teams have clear guidance, templates, timelines, and expectations
Bring creative, practical solutions to regulatory challenges inherent in AI technology in the healthcare space
Build lightweight regulatory processes appropriate for a startup environment without sacrificing compliance
Use regulatory knowledge to enable innovation, not block it - finding pathways that support speed, safety, and responsible AI
Identify gaps in regulatory readiness and implement corrective actions proactively
Contribute to internal playbooks, templates, and scalable processes across regulatory and compliance functions
Qualification
Required
10-12 years of regulatory affairs experience spanning medical devices, digital health, pharmaceuticals, and 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
Preferred
Experience working in a startup or emerging-growth private company
Prior leadership experience building regulatory frameworks or managing cross-functional initiatives
PhD, PharmD or Master's degree preferred. RAC certification or equivalent is a plus
Company
Hippocratic AI
Hippocratic AI is a healthcare technology company that develops safety-focused large-language models for medical applications.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$402MKey Investors
AvenirKleiner PerkinsNVentures
2025-11-03Series C· $126M
2025-01-09Series B· $141M
2024-09-19Series A· $17M
Leadership Team
Alex Miller
Co-Founder
Amy McCarthy
Chief Nursing Officer
Recent News
MedCity News
2026-01-17
2026-01-16
2026-01-15
Company data provided by crunchbase