Experienced Regulatory Affairs Manager with a demonstrated history of working in the medical device industry. Legal professional, specialised in European and Dutch directives/regulations for Medical Devices. Strong social skills and eager to learn. Skilled in Medical Devices, Health Law, Quality Management.
Annette gained significant experience with a broad variety of medical devices working at TÜV Rheinland and serving as Inspector of Medical Technology at the Dutch Health and Youth Care Inspectorate (“IGJ”). She represented the IGJ within the European Competent Authorities working group for Compliance and Enforcement and is currently main contact towards European Competent Authorities. Areas of expertise include European medical device legislation, borderline issues, classification of (medical) devices and Competent Authority supervision. Over the past years Annette has been intensively involved in the implementation of the Medical Device Regulation (EU) 2017/745 (“MDR”), and contributed to national and European guidance documents on the MDR.