Director of Quality & Regulatory Affairs

About the role

We are seeking an experienced leader to head the global Quality and Regulatory Affairs function for our multi‑site medical device contract manufacturing operations. The role will shape the quality strategy, ensure regulatory compliance, and drive continuous improvement across facilities in Costa Rica, the United States and future locations.

Key responsibilities

• Define and execute the global Quality & Regulatory Affairs strategy for medical‑device manufacturing.
• Maintain compliance with FDA, ISO 13485, EU MDR, MDSAP, GMP and other international regulations.
• Lead regulatory submissions, FDA inspections, audits and inspection readiness activities.
• Own and continuously improve the global Quality Management System (QMS).
• Oversee CAPA, non‑conformance, supplier quality, complaint handling, post‑market surveillance, risk management, validation and internal audits.
• Set quality objectives, KPIs and standardized processes across all manufacturing sites.
• Partner with Operations, Engineering, Manufacturing, Supply Chain and R&D to embed quality and operational excellence.
• Drive Lean Manufacturing, Six Sigma and other continuous‑improvement initiatives.
• Build, coach and develop high‑performing Quality and Regulatory teams in multiple locations.

Required profile

• Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs or a related technical field.
• 15+ years of progressive experience in Quality and Regulatory Affairs within the medical‑device industry.
• 8+ years of people‑leadership experience, including management of senior professionals.
• Proven track record supporting multi‑site manufacturing operations and leading FDA inspections.
• Fluency in English and Spanish (written and verbal).

Required skills

• FDA 21 CFR Part 820 compliance
• ISO 13485 implementation
• EU MDR and MDSAP knowledge
• ISO 14971 risk‑management
• CAPA and non‑conformance management
• Supplier quality and complaint handling
• Validation and design‑control processes
• Lean Manufacturing and Six Sigma methodologies