• Medical Device Quality and Regulatory Leader with more than 20 years of experience in product development, medical device software life cycle, quality management systems, software quality assurance, regulatory submissions, quality audits and IT compliance. • Achieved US FDA-accredited third-party 510k reviewer status and directly collaborated with the FDA as accredited third-party 510k reviewer (1 out of 7 worldwide). Recommended SE (Substantially Equivalent) or NSE (Non-Substantially Equivalent) decisions to the FDA.• Led various regulatory, product development, information security, data privacy, quality improvement projects in product development and IT environments governed by the FDA, EU MDR, ISO, DOD, and Data Privacy regulations. Also lead and participated in projects within dynamic entrepreneurial environments that required a highly adaptive approach to development and testing.Professional Competencies• Quality Management System (21 CFR 820, 21 CFR Part 11, ISO 13485, ISO 9001)• US Regulatory Submissions such as 510k, PMA etc. (FDA Guidances for pre-market submissions)• EU MDR and IVDR regulatory Conformity Assessments preparations (EU MDR and EU IVDR)• Medical Device Software Life Cycle including Validation (IEC 62304 and IEC 82304)• Software as Medical Device (IMDRF and FDA Guidances) • Product Development and Design Controls (21 CFR 820, ISO 13485, IEC 62304)• Quality Audits preparation and support (including FDA, BSI, MDSAP, client, supplier and internal)• Risk Management (ISO 14971 and IEC 80002-1) including AI/ML hazards (AAMI CR34971:2022)• Cybersecurity (FDA Guidances for pre-market and post-market cybersecurity) • Human Factors Engineering (FDA Guidance and IEC 62366)• Data Privacy and Information Security (HIPAA, GDPR, CCPA, ISO 27001)• Localization and Internationalization • Risk-Based Quality System (Non-Product) Software Validation (FDA General Principles of Software Validation, GAMP5 and IEC 80002-2)