The Director, Healthcare Global Regulatory Affairs and Public Policy is a leadership role responsible for shaping and advancing GS1’s global healthcare regulatory and public policy agenda. The role operates at the intersection of healthcare regulation, international standards, and digital health, engaging at senior levels with regulators, governments, industry associations, and global institutions to support the adoption of harmonised, standards-based regulatory frameworks.

The role works in close alignment with GS1’s public policy strategy and plays a critical role in positioning GS1 as a trusted global partner in healthcare regulation, interoperability, identification, and traceability.

Role Purpose
The Director leads GS1’s global healthcare regulatory engagement to enable safer patient outcomes through improved data quality, interoperability, and traceability. The role anticipates and responds to regulatory and policy developments worldwide, translating them into strategic engagement, thought leadership, and practical adoption of GS1 standards across diverse regulatory environments.

Operating in a complex, multicultural, and matrixed global context, the role delivers outcomes primarily through influence, credibility, and alignment rather than formal authority.

Responsibilities:

Lead the development and execution of GS1’s global healthcare regulatory and public policy strategy, aligned with GS1’s broader enterprise public policy priorities.
Engage at senior levels with governments, international organisations, regulators, and authorities across medicines, MedTech, and digital health domains.
Build and sustain strategic relationships with global and regional industry associations and healthcare stakeholders to support regulatory alignment and standards adoption.
Provide recognised subject matter expertise and thought leadership through position papers, policy inputs, and strategic guidance supporting implementation of GS1 standards.
Represent GS1 as a credible and neutral voice at international regulatory forums, conferences, and policy meetings.
Lead and develop a global regulatory and regional engagement team, ensuring effective delivery against strategic objectives and capability building across regions.
Collaborate closely with GS1 Member Organisations and internal teams to support education, regulatory alignment, and coordinated global engagement.

Future Focus
A key focus of the role is strengthening GS1’s positioning within the evolving digital health ecosystem. This includes supporting regulatory innovation, enabling digitised regulatory processes, and reinforcing the value of international standards in accelerating safe, interoperable, and efficient healthcare systems worldwide.

Education/Experience:

Minimum 10 years’ experience in pharmaceutical and/or MedTech regulatory environments, with demonstrated ability to engage effectively with healthcare authorities and regulators.
Relevant industry experience within a healthcare manufacturer, supplier, wholesaler, or related organisation; practical experience with GS1 standards is a strong advantage.
Proven success operating in complex, international, and multicultural environments.
Demonstrated track record in roles requiring neutrality, credibility, and influence, where outcomes are achieved through alignment and persuasion.
Experience in global health, digital health, or standards-related regulatory initiatives is highly desirable.

Skills required:

Deep understanding of pharmaceutical and MedTech regulatory frameworks and stakeholder expectations.
Experience in leading teams, aligning for success, coaching and developing others. One direct report.
Strong network of senior regulator connections across the Southern hemisphere.
Working knowledge of regulatory environments in developing and transitional markets, including the Southern Hemisphere.
Strong collaboration and stakeholder engagement skills within matrixed, global organisations.
Excellent written and verbal communication skills in English, with the ability to engage diverse audiences at senior levels.
High cultural intelligence, adaptability, and commitment to knowledge sharing and capability building across teams.

Additional Information:

• Up to 33% global travel may be required.
• GS1 is an Equal Opportunity Employer.

Director, Healthcare Global Regulatory Affairs and Public Policy - GS1

Shape the future of global healthcare regulation. Engage top regulators worldwide and drive standards adoption to power safer, smarter and truly interoperable digital health systems.