Deputy Director, AI Regulatory Policy, Center of Digital and Data Excellence

Deputy Director, AI Regulatory Policy at PATH

PATH is a global nonprofit dedicated to achieving health equity. PATH’s AI Initiative pioneers the use of generative AI and advanced digital technologies to accelerate biomedical discovery, strengthen regulatory systems, and enhance safety and scalability of digital healthcare.

Role Overview

The Deputy Director leads PATH’s global portfolio on AI‑related regulatory policy and system strengthening. In the near term, this includes oversight of a first‑of‑its‑kind regulatory sandbox for AI‑enabled mental health products. Beyond this, the Deputy Director coordinates PATH’s wider regulatory policy efforts for AI‑enabled medical devices, including:

• Supporting AI‑aMD manufacturers with regulatory submissions aligned with PATH’s mission.
• Providing strategic input into global regulatory harmonization initiatives.
• Advising internal governance and research teams on AI regulation, evaluation, and compliance.

Requirements: dynamic policy strategist who combines technical understanding of AI regulation with operational experience in multilateral collaboration, stakeholder engagement, and capacity‑building across LMIC contexts.

Responsibilities

• Technical Leadership – Lead design and delivery of a regulatory sandbox for AI‑enabled health products, partner with regulatory agencies and academic partners.
• Lead technical assistance to partner governments on regulatory pathways, legal frameworks, and policy toolkits.
• Lead conception and writing of white papers, policy briefs, and thought leadership on regulatory innovation, sandbox governance, and ethical AI oversight.
• Oversee regulatory training activities, including development of a postgraduate certificate programme in AI regulation.
• Advise and support AI‑enabled health technology developers in preparing for national regulatory submissions.
• Project Execution & Programme Coordination – Serve as responsible party for initiative‑led projects, ensure compliance with PATH and donor research ethics and data protection standards, and timely delivery of outputs.
• Collaborate with project finance managers to match day‑to‑day spending to budgeted spend, and secure funding.
• Collaborate with other AI Deputy Directors and the AI programme manager to contribute to the overall culture and control environment.
• Management and Mentorship – Matrix manage staff on projects led by the Deputy Director; provide technical mentorship to peers and junior staff; hire and manage a dedicated AI regulatory policy team by year 2.
• Programme‑Wide Responsibilities – Serve as internal subject matter expert on AI as a medical device; contribute to PATH’s internal AI governance framework; lead business development activities; stand in for the Chief AI Officer as required.

Required Skills & Experience

• PhD in regulatory science or innovative product development with relevant regulatory experience.
• 7+ years in medical device regulation, digital health policy, or AI governance (public sector or industry regulatory affairs).
• Demonstrated experience leading complex, multi‑partner projects with governments, regulators, and donors.
• Proven understanding of global regulatory harmonization frameworks (e.g., IMDRF).
• Familiarity with ethical and legal aspects of AI as a medical device, including post‑market surveillance, data protection, and algorithmic transparency.
• Experience leading sandbox or pilot initiatives with regulators (e.g., MHRA AI Airlock).
• Understanding of WHO and regional PQ processes for digital or AI‑based health products.
• Strong analytical and writing skills, with a record of influential policy outputs.
• Proven track record of working effectively in cross‑cultural, multidisciplinary teams.
• Comfort navigating uncertainty and pioneering regulatory solutions in emerging fields.

EEO Statement

We know great candidates won’t always meet every listed qualification. If you’re excited about the role and think you’d be a good fit, we encourage you to apply.

To be selected, you must have legal authorization to work in the UK.