Director of Quality and Regulatory Affairs

About the role

RECLUTAMIENTO is looking for an experienced Quality and Regulatory Affairs leader to drive the global Quality Management System (QMS) and regulatory strategy across multi-site medical device contract manufacturing operations in Costa Rica, the United States, and future international locations.

Responsibilities

• Lead the global Quality and Regulatory Affairs strategy for medical device manufacturing.
• Ensure compliance with FDA, ISO 13485, EU MDR, MDSAP, GMP, and international regulations.
• Lead regulatory submissions, FDA inspections, regulatory audits, and inspection readiness.
• Own and continuously improve the global Quality Management System (QMS).
• Oversee CAPA, nonconformance management, supplier quality, complaint handling, post-market surveillance, risk management, validation, and audits.
• Establish quality objectives, KPIs, and standardized processes across multiple manufacturing sites.
• Partner with Operations, Engineering, Manufacturing, Supply Chain, and R&D to drive quality and operational excellence.
• Lead continuous improvement initiatives using Lean Manufacturing, Six Sigma, and other methodologies.
• Build, coach, and develop Quality and Regulatory teams across multiple locations.

Requirements

• 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 managing senior professionals and managers.
• Experience supporting multi-site manufacturing operations and international manufacturing operations.
• Demonstrated success leading FDA inspections.
• Extensive knowledge of ISO 13485, MDSAP, FDA 21 CFR Part 820, ISO 14971, Design Controls, CAPA, Complaint Handling, Supplier Quality, and Validation.
• Fluency in English and Spanish.

Datos clave

• The role leads global Quality and Regulatory Affairs strategy for medical device manufacturing.
• The position requires 15+ years of progressive industry experience.
• The role requires fluency in English and Spanish.
• The role involves operations in Costa Rica, the United States, and future international locations.