Director of Quality and Regulatory Affairs

📢 We're Hiring | Director of Quality & Regulatory Affairs 🏭⚕️
We are looking for an experienced Quality & 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.
🔹 Key Responsibilities: ✅ Lead the global Quality & 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 high-performing Quality and Regulatory teams across multiple locations.
🎯 What We're Looking For: ✔ 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. ✔ Proven experience supporting multi-site 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. ✔ Experience with international manufacturing operations. ✔ Fluency in English and Spanish (written and verbal).
⭐ Preferred Qualifications: ➕ Master's degree in Engineering, Business Administration, or related field. ➕ ASQ certifications (CQE, CQA, CMQ/OE) or RAC. ➕ Lean Six Sigma Green Belt or Black Belt. ➕ Experience with Class II/III medical devices. ➕ Experience supporting manufacturing operations in Latin America.