With 18 years of experience in quality systems and regulatory affairs, I bring a wealth of knowledge and expertise to the medical device, in-vitro diagnostics (IVD) and combination products industries. My career has been dedicated to ensuring that products meet the highest standards of quality and compliance, enabling safe and effective solutions for healthcare. I have successfully established quality systems for both start-up ventures and multi-national organisations, adhering to the stringent requirements of ISO 13485, 21 CFR parts 4 and 820, MDSAP and EU GMP Vol. 4, Part I. My work has spanned the full spectrum of quality management, from developing regulatory submission strategies to completing successful product registrations on a global scale.Key Achievements: • Spearheaded the development and implementation of quality systems that have passed rigorous audits by regulatory authorities, notified bodies and certification bodies.• Led regulatory submission efforts resulting in the successful market entry of numerous medical devices and IVD products.• Expertly managed audits and inspections, consistently achieving compliance and maintaining certification status across various jurisdictions.I am passionate about driving continuous improvement in quality management processes and regulatory strategies. My goal is to contribute to the advancement of medical technologies that enhance patient outcomes and meet evolving regulatory requirements.