ProfileAccomplished regulatory affairs and quality management professional with over a decade of experience in the medical device industry. Expert in developing, implementing, and optimizing quality management systems (ISO 13485, ISO 9001) and ensuring compliance with international regulatory requirements (EU MDR/IVDR, FDA, MDSAP). Proven track record in preparing technical documentation for Class I?III devices, managing global submissions, and leading organizations through successful audits and inspections. Skilled in risk management, post-market surveillance, and continuous process improvement. Recognized for strategic thinking, cross-functional leadership, and the ability to drive regulatory and quality excellence in dynamic, international environments.
Key Competencies- Regulatory affairs & quality management (MDR, FDA, ISO 13485, MDSAP)
- Development, implementation, and gap assessment of ISO 13485
- Creation of MDR/IVDR technical documentation (Class I?III)
- Regulatory strategy and international submissions (CE, FDA, MFDS, SFDA, Brazil, etc.)
- FDA inspection readiness, CAPA/NC management, complaint handling, and recall strategy
- Post-Market Surveillance & Vigilance (EU MDR/IVDR), including PMCF/PMPF
- Auditing and compliance (Lead Auditor, MDSAP, ISO 13485)
- Process improvement and QMS integration projects
- Workshop and training facilitation
Summarized Project & Consulting Achievements- Successful market launch of several medical devices (class I,IIa,IIb,III) in Europe and the USA
- Conducted and led over 50 international audits (MDR, MDSAP, ISO 13485)
- Establishment and digitalization of QM systems in growing companies
- Developed and implemented approval strategies for global markets
- Introduced KPIs and performance management systems in development departments