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PATH

Global nonprofit advancing health equity solutions

AI Fellow - Regulatory Policy, AI for Health

Social & Behavioral SciencesPosted on Nov 11
Full-timeLondon, UKNo salary listed

About the Job

Requirements

  • A Master of Science or PhD, or equivalent, in law, public policy, regulatory science, public health, health policy, biomedical engineering, or a related discipline, or equivalent professional experience in a regulatory, quality, or compliance role.
  • At least two years of experience beyond the degree in regulation, governance, or oversight of health products, in a national regulatory authority, notified body or conformity assessment body, medical device or digital health company, consultancy, or research organisation.
  • Working knowledge of medical device regulation and related requirements, including quality management systems such as ISO 13485, risk management, software lifecycle processes, clinical evaluation, and post-market surveillance; knowledge of how SaMD and AIaMD are treated by the IMDRF and leading regulators such as MHRA and FDA.
  • Research experience with evidence of scientific or policy writing, such as publications, preprints, policy reports, or a thesis, and familiarity with qualitative and mixed methods, including document and legal analysis, key informant interviews, and comparative case studies.
  • Ability to communicate in writing and verbally for regulatory, policy, academic, and public audiences, including explaining technical AI concepts to regulators and regulatory concepts to AI specialists.
  • Ability to convene and facilitate meetings and workshops with senior stakeholders, coordinate work and deadlines across complex multi-stakeholder projects, and work tactfully and discreetly with government institutions.
  • Ability to handle sensitive material, including product dossiers and mental health content, with care.
  • Legal authorization to work in the United Kingdom.

Responsibilities

  • Study regulatory sandboxes and post-market oversight arrangements, document lessons learned, and prepare insights for dissemination in academic literature and to policymakers and wider audiences.
  • Research the state of medical device regulation across sub-Saharan Africa, including regulatory authorities’ mandates and pathways for medical devices, SaMD, and AIaMD; staffing and resources; WHO Global Benchmarking Tool standing; and reliance, recognition, and regional harmonisation mechanisms.
  • Conduct desk research on legislative reforms needed to drive national and continental action and the potential value of mental health-specific instruments.
  • Conduct qualitative research with regulatory authorities’ medical device leads and manufacturers, particularly developers of mental health-relevant tools, to characterize challenges and priority interventions.
  • Use patient simulation and benchmarking projects to test assumptions embedded in existing legislation or regulatory approaches.
  • Work with technical experts to assess the implications of frontier, general-purpose, and generative AI for medical device frameworks, quality management system requirements, and regulators’ ability to verify products.
  • Coordinate research compliance with PATH’s Office of Research Affairs and institutional and funder requirements; prepare protocols and shepherd them through ethics review and required approvals at PATH and relevant national committees.
  • Maintain research records and contribute to donor reports, read-outs, and progress updates for funders and partners.
  • Work with PATH’s Chief AI Officer and experts from CERSI-AI, PATH, and its consultant network to convene the right participants, set agendas, prepare sessions, record decisions, and ensure actions are taken.
  • Support delivery of the regulatory sandbox by working with the MCAZ technical secretariat to plan co-design workshops, identify and brief participants, prepare pre-reads, and record decisions and assigned actions.
  • Develop and drive the capacity-strengthening programme with the Chief AI Officer, drawing on CERSI-AI learning-needs assessments and MCAZ feedback to engage training partners and assess whether training changes regulatory practice.
  • Contribute to oversight of partner contributions, including CERSI-AI’s development of a postgraduate certificate programme in regulation of AI as a medical device, and maintain accountability for delivery timelines.
  • Develop a workback plan for delivery of the sandbox white paper and playbook for the African Medicines Agency, write components where appropriate, and keep internal and external partners accountable for their contributions.

Desired Qualifications

  • Experience working with or within a national regulatory authority or regional body, ideally in sub-Saharan Africa or another low- or middle-income setting, such as the African Medicines Agency or the African Medicines Regulatory Harmonisation initiative.
  • Familiarity with the WHO Global Benchmarking Tool and regulatory system maturity assessment, or with reliance and recognition pathways.
  • Understanding of machine learning and large language models sufficient to engage with validation, change control such as predetermined change control plans, post-market monitoring, and regulatory implications of general-purpose and generative models.
  • Experience organising, developing, or delivering professional training or curricula for regulators, clinicians, or policy audiences.
  • Experience with regulatory sandboxes or other experimental regulatory mechanisms, such as the MHRA’s AI Airlock.
  • Experience in digital mental health, evaluation of digital health products, or AI in health research.
  • Experience working in international research consortia, including contributing to donor reports.

About the Company

PATH

Global nonprofit advancing health equity solutions

PATH is a global nonprofit focused on health equity. It builds and scales solutions to major health challenges by forming multisector partnerships that draw on expertise in science, economics, technology, advocacy, and other fields. Rather than offering a single product, PATH designs, tests, and expands programs, tools, and policies that can be adopted by partners and governments to improve health outcomes. What sets PATH apart is its nearly 50 years of field experience across diverse disciplines and its emphasis on collaboration to move proven ideas into real-world impact at scale. The organization’s goal is to achieve lasting health equity by ensuring access to effective health innovations, services, and practices for people worldwide.

Company size
1,001-5,000
Company stage
Grant
Total funding
$26.6M
Headquarters
Seattle, WA
Founded
1977

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