DIRECTOR OF REGULATORY INNOVATION & POLICY

HealthAI is a Geneva-based, not-for-profit organization serving as a trusted implementation partner for governments worldwide. We collaborate with multiple government, public, and private partners to ensure the innovative, safe, and responsible introduction of AI in healthcare systems. Our mission spans high, middle, and low-income countries, bridging regulatory frameworks to ensure equitable access to safe AI technologies while maintaining compliance with medical device regulations, data privacy laws, and emerging AI governance frameworks.

Position Summary

HealthAI is seeking an exceptional Director of Regulatory Innovation and Policy to lead our global regulatory strategy and policy development initiatives. This pivotal role combines deep regulatory expertise with innovation leadership, shaping how governments worldwide implement AI in healthcare. The successful candidate will navigate complex international regulatory landscapes to help build regulatory capacities, promote global regulatory alignment within local contexts, and ensure HealthAI remains at the forefront of responsible AI deployment.

Role Purpose & Impact

Reporting to the Chief Regulatory Officer, with direct collaboration with the CEO and Chief Scientist, this role will contribute to establishing HealthAI as the global thought leader in the responsible and regulated implementation of AI. The chosen candidate will translate complex regulatory requirements, such as the EU MDR/IVDR, FDA, IMDRF, and MDSAP frameworks, into actionable implementation steps for diverse government, public, and private partners, with a particular focus on adapting these frameworks for LMICs across all continents.

Key Responsibilities

• Global Policy Leadership & Technical Advisory
  • Integrate global AI policies, research, and regulatory frameworks to position HealthAI as the authoritative voice on responsible AI in healthcare
  • Through the HealthAI Global Regulatory Network (GRN) programme, review, evolve and help deliver regulatory capability-building programs tailored to different country regulatory baseline contexts
  • Co-develop HealthAI position papers on critical AI topics including, regulatory sandboxes, liability, implementation and monitoring
  • Analyze regulatory alignment and harmonization initiatives, particularly focusing on LMIC implementation strategies
• Innovation & Technical Thought Leadership
  • Collaborate with research institutions and innovation hubs to identify emerging regulatory challenges in AI/ML-enabled medical devices
  • Drive discussions on algorithm change protocols, continuous learning systems, and adaptive AI validation requirements
  • Bridge innovation and regulation, ensuring responsible deployment without stifling technological advancement
  • Mentor internal teams on global regulatory requirements and emerging AI in healthcare policies
  • Identify and implement AI technologies to enhance organizational efficiency for regulatory activities within the HealthAI GRN

Required Qualifications & Experience

• Education
  • Bachelor’s degree in life sciences, engineering, law, public health, social sciences or other relevant subject
  • Advanced degree preferred (Master’s, PhD, or equivalent)
• Experience
  • Minimum 5 years in medical device regulation, health policy, or AI governance
  • Demonstrated experience working directly with government regulators, international organizations (e.g. WHO, IMDRF), or in similar AI policy or research roles, specifically with a healthcare focus
  • Proven track record in policy development and implementation at national, regional or international level
  • Experience navigating multiple regulatory frameworks (e.g. FDA, CE marking, MDSAP) with evidence of successful cross-border projects
• Regulatory Expertise
  • Deep understanding of medical device regulations across major markets
  • Expertise in AI/ML regulatory considerations, including predetermined change control plans, good machine learning practices, and clinical validation requirements
  • Strong familiarity with relevant global standards, e.g. ISO 13485, IEC 62304, ISO 14971 and emerging AI standards
• Essential Competencies
  • Strategic Thinking: Ability to synthesize complex global regulatory landscapes into actionable strategies
  • Cultural Intelligence: Navigate diverse regulatory philosophies and healthcare system contexts
  • Cultural Sensitivity: Ability to collaborate productively with a culturally diverse, international team
  • Communication Excellence: Translate technical regulatory concepts for diverse stakeholders from policy makers to technical teams
  • Diplomatic Skills: Build consensus among stakeholders with competing priorities
  • Systems Thinking: Understand interconnections between regulation, innovation, and healthcare delivery
  • Adaptability: Ability to work within a small organization and to apply established frameworks creatively in resource-constrained environments

What We Offer

• Opportunity to shape global AI healthcare policy impacting millions of lives
• Collaboration with leading experts across regulation, innovation, and public health
• Flexible, mission-driven work environment
• Professional development opportunities, including conference participation and publication support
• Competitive not-for-profit sector compensation package

How To Apply

• Applications should be submitted in English and by email only. The following set of documents is required:
  • A cover letter explaining your suitability to fulfil this assignment (1-page limit);
  • A CV detailing relevant past experiences, as well as indicating your current location and nationality / work permit for Switzerland, if applicable (2-page limit)
• Swiss citizenship and work permit, or EU citizenship and willingness to relocate to Switzerland, strongly preferred. Complete applications should be sent to the HR department (hr@healthai.agency) with the subject “Application: Director of Regulatory Innovation and Policy”. Please include the required attachments merged into a single PDF.
• Deadline for submissions: 15 October 2025 (midnight, CEST). Please note that incomplete applications will not be accepted. We are committed to diversity and especially encourage members of underrepresented communities to apply.  Due to the large number of applications, we are only able to inform the successful candidates about the outcome or status of the selection process.

Ready to Help Us Reimagine Health?

If you’re excited about working at the intersection of AI, regulations, and healthcare, we’d love to meet you. Apply now