Director, QARA LATAM – Quality Assurance & Regulatory Affairs

About the role

The Director, QARA LATAM, Distribution & Ops provides strategic leadership for quality assurance and regulatory affairs across Latin America. Reporting to the International QARA organization, the role ensures compliance, effective quality system execution, and sustainable market access in highly regulated markets.

Key responsibilities

• Lead and execute the Quality Assurance and Regulatory Affairs strategy across LATAM in line with global QARA objectives.
• Ensure ongoing compliance with country‑specific regulatory requirements.
• Partner closely with Commercial, Operations, Supply Chain, Legal and Global QARA leaders to manage quality and regulatory risk.
• Guide regional strategy to safeguard patient safety and support compliant business growth.

Required profile

• Proven experience in quality assurance and regulatory affairs within the medical device or pharmaceutical industry.
• Demonstrated ability to lead cross‑functional teams across multiple LATAM markets.
• Strong knowledge of country‑specific regulatory frameworks and market access requirements.

Required skills

• Regulatory affairs expertise
• Quality management system (QMS) implementation and oversight
• Understanding of Latin America regulatory requirements

What we offer

• Opportunity to shape regional quality and regulatory strategy for a global healthcare leader.
• Collaboration with diverse functional teams across the organization.
• Potential transition to DePuy Synthes following corporate separation.