Head of Regulatory Affairs

Head Of Regulatory Affairs

The Head Of Regulatory Affairs is responsible for leading and executing global and domestic regulatory strategy, filings, and compliance activities for (a) clinical trials for pharmaceuticals, biologics, and medical devices, and (b) 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 General Counsel, and will work closely with our legal, pharma, clinical, and IT teams.

The responsibilities include:

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: 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.

Regulatory Compliance

• 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.

Cross-Functional Leadership

• 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.

Innovation & Process Building

• 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.

The ideal candidate will bring:

Must-Have:

• 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.

Nice-to Have:

• 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.

We're looking for a regulatory leader who combines strategic thinking with detailed operational follow-through. Someone who respects regulatory structure but is creative, innovative, and solutions-oriented. A builder who wants to create the regulatory foundation for both advanced AI systems and traditional drug/device programs. A collaborator who can work seamlessly with clinical, technical, product, and executive teams.