Regulatory Affairs• Strong experience in matter of QA/RA in product design and development process for new or changed products • Sound knowledge and working experience of quality management system, standards and government regulations applicable to medical devices e.g. ISO 13485, 21 CFR 820 QSR, MDR 2017/45. • Strong experience in the compliance process (relationship with external testing houses and agencies/notified bodies).• Strong experience in the application of safety process standards (e.g. ISO 14971, IEC 62304) during the design and development• Driving design and implementation of processes for digitalization including PCCP and AI Risk Management• Clear understanding of the Cost of Poor Quality• Business and political acumen in FDA 510(k), NMPA, HC, ANVISA/INMETRO, CDSCO registration procedure.• Authored FMEA and traceability matrix. Multicultural experience and strong language skills with Dutch (native), English and Italian fluency, and conversational German skills.Courses:- Effective medical device registration in international markets- Applying ISO14971:2​012 and IEC62304 - A Guide to Practical Risk Management​#nobuzzwords