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 within the International QARA organization. This senior position ensures regulatory compliance, effective quality‑management system execution, and sustainable market access while safeguarding patient safety and supporting long‑term portfolio success.

Key responsibilities

• Lead and execute the Quality Assurance and Regulatory Affairs strategy across LATAM in alignment with global QARA objectives and business priorities.
• Ensure ongoing compliance with country‑specific regulatory requirements and maintain an effective quality‑management system.
• Partner closely with Commercial, Operations, Supply Chain, Legal, and Global QARA leaders to manage quality and regulatory risk.
• Guide regional strategy to enable compliant business growth and market access.
• Support the transition to DePuy Synthes and align local processes with the new organization’s policies and programs.

Required profile

• Proven leadership experience in quality assurance and regulatory affairs within the medical‑device or healthcare sector.
• Deep knowledge of LATAM regulatory environments and country‑specific compliance requirements.
• Ability to influence cross‑functional teams and drive strategic initiatives.
• Strong commitment to patient safety and product quality.

Required skills

• Regulatory affairs expertise for Latin American markets.
• Quality‑management system implementation and oversight.
• Strategic planning and execution in a multinational context.