Vice President, Global Quality, Regulatory & Clinical Affairs - CGM+

VICE PRESIDENT, GLOBAL QUALITY, REGULATORY & CLINICAL AFFAIRS - CGM+

Help Define the Regulatory Future of AI-Enabled Biosensors

Location: This role can be based in the United States or in Ireland

International Travel Required

Trinity Biotech (NASDAQ: TRIB) is seeking an exceptional leader to join our executive team as Vice President, Global Quality, Regulatory & Clinical Affairs - CGM+.

Reporting directly to the CEO, this executive will play a critical role in shaping the regulatory, quality and clinical strategy for CGM+, Trinity Biotech's next-generation biosensor platform. The platform combines continuous glucose monitoring with additional physiological sensing capabilities and is intended to support future advances in metabolic health, digital health and AI-enabled healthcare.

This is a rare opportunity to help define regulatory pathways for innovative healthcare technologies while building the quality and clinical foundations required to support global commercialisation.

What You'll Lead

• Global Regulatory Strategy
• FDA, CE Mark and International Approvals
• Quality Assurance & Quality Systems
• Clinical Affairs & Evidence Generation
• AI & Software Regulatory Strategy
• Post-Market Quality & Surveillance
• Regulatory Advocacy & Industry Engagement

What We're Looking For

• 15+ years of leadership experience in Regulatory Affairs, Quality and/or Clinical Affairs
• Medical devices, diagnostics, digital health, biosensors or wearable technology experience
• Track record of successful FDA and European approvals
• Experience with innovative technologies and evolving regulatory frameworks
• Strong quality systems and manufacturing quality leadership
• Ability to build and lead high-performing international teams

Why Join Trinity Biotech?

• Direct report to the CEO
• Executive leadership role with significant strategic influence
• Opportunity to help shape regulatory acceptance of novel healthcare technologies
• Influence quality, clinical and regulatory strategy globally
• Meaningful equity participation opportunity
• Work at the intersection of biosensors, diabetes technology, digital health and AI-enabled healthcare
• This is more than a regulatory leadership role. It is an opportunity to help define how innovative biosensor platforms are brought to market, while building the quality, regulatory and clinical capabilities required to support long-term global success.