Expert Quality and Regulatory Consulting / Freelance, PRRC and Management Representative

Expert Quality and Regulatory Consultant / Freelance, PRRC and Management Representative with 20+ years of experience driving quality and regulatory compliance across MedTech, BioTech, Pharma and manufacturing industry. Proven track record of building and scaling QMS frameworks from scratch under ISO 13485, ISO 9001, MDR, FDA (21 CFR Part 820 and Part 11), and GxP regulations. Expert in global qualification / verification / validation (incl. CSV), Technical File management (DHF/DMR/DHR) for Class I until class III medical devices, and leading cross-functional teams through successful internal, external and supplier audits. I combine a solid technical foundation in Computer Engineering with strong leadership skills to seamlessly bridge the gap between engineering, quality operations, and international regulatory compliance.