Director of Quality & Regulatory Affairs - Medical Devices (FDA 510(k))

About the role

A rapidly expanding medical device contract manufacturer is seeking a Director of Quality & Regulatory Affairs to lead global quality and regulatory strategy. The role oversees Quality Management Systems, regulatory compliance and quality operations across manufacturing facilities in Costa Rica, the United States and future international locations.

Key responsibilities

• Develop and execute regulatory strategies for manufacturing, product development and international expansion, and lead FDA 510(k) submissions, documentation, agency interactions and approvals.
• Ensure compliance with FDA 21 CFR Part 820 (QMSR), ISO 13485, EU MDR, MDSAP and other international requirements, and liaise with the FDA, notified bodies and regulators.
• Lead global Quality Management Systems, QA, QC, CAPA, supplier quality, risk management, complaints and post-market surveillance.
• Direct FDA inspections, ISO audits, customer audits and inspection readiness, and set and monitor quality KPIs.
• Support new product introductions, process validations, manufacturing transfers and continuous improvement.
• Build and lead multidisciplinary Quality and Regulatory teams, partner with Operations, Engineering, Manufacturing, Supply Chain and R&D, and standardize quality processes across sites.

Required profile

• Bachelor's degree in engineering, Life Sciences, Quality Management, Regulatory Affairs or a related field.
• 15+ years in Quality Assurance, Regulatory Affairs or Quality Management in medical devices; 8+ years of leadership experience.
• Mandatory hands-on experience leading, preparing or managing FDA 510(k) submissions, and leading FDA inspections and regulatory audits.
• Experience overseeing quality and regulatory operations across multiple manufacturing facilities.
• Full professional fluency in English and Spanish, written and spoken.
• Preferred: Master's degree, RAC, ASQ CQE/CQA/CMQ/OE or Lean Six Sigma certification, Class II/III device experience, contract manufacturing leadership, EU MDR submissions and international registrations.

Required skills

• ISO 13485, FDA 21 CFR Part 820/QMSR, EU MDR, MDSAP, ISO 14971, CAPA, design controls and QMS
• Medical device manufacturing, supplier quality, validation and regulatory compliance
• Strategic leadership, stakeholder management and communication