Director of Quality & Regulatory Affairs – Contract Manufacturing

About the role

The Director of Quality & Regulatory Affairs – Contract Manufacturing leads the global Quality Management System (QMS) and regulatory strategy for a multi‑site medical device operation spanning Costa Rica, the United States and future locations. This executive role ensures compliance with FDA, ISO, EU MDR and other international requirements while fostering a culture of quality, continuous improvement and operational excellence.

Key responsibilities

• Develop and execute a global regulatory strategy for all medical‑device products, ensuring compliance with 21 CFR Part 820, ISO 13485, EU MDR, MDSAP and related standards.
• Lead regulatory submissions including 510(k) filings, technical files, letters to file and international product registrations.
• Serve as primary liaison with FDA, notified bodies and other regulatory authorities; lead FDA inspections and audits.
• Own and continuously improve the company’s QMS, establishing quality objectives, KPIs and overseeing management review meetings.
• Oversee quality assurance, non‑conformance management, supplier quality onboarding, process validation, CAPA, post‑market surveillance, complaint handling and risk management.
• Partner with Operations, Engineering, Manufacturing, Supply Chain and R&D to ensure alignment of quality and regulatory activities across sites.

Required profile

• Executive‑level leader with extensive experience in FDA regulations, ISO 13485, EU MDR and multi‑site medical‑device manufacturing environments.
• Proven ability to develop and maintain a robust QMS and drive regulatory compliance across global operations.
• Fluent in English and Spanish, capable of communicating with teams and authorities in both languages.
• Strong track record of leading FDA inspections, regulatory audits and successful product registrations.

Required skills

• FDA Quality System Regulation (21 CFR Part 820)
• ISO 13485
• EU Medical Device Regulation (MDR)
• MDSAP
• 510(k) and other regulatory submissions
• Technical Files and Letters to File
• Post‑Market Surveillance
• CAPA (Corrective and Preventive Actions)
• Risk Management
• Internal Auditing and Inspection Readiness
• Document Control and Change Management
• Supplier Quality Management