7 August 2020
Sabina Hoekstra-van den Bosch was elected as one of the Chairs of the NB-MED Executive Committee with effect from July 1, 2020. NB-MED is the official working group of the EU Notified Bodies notified under the Directives/Regulations for medical devices and IVDs. She replaces Hans Heiner Junker, Senior International Affairs Manager at TÜV SÜD, in his function as current chairman of NB-MED.
A few months ago, Hoekstra-van den Bosch was appointed Regulatory Strategy Principal in the Medical Health Services division of TÜV SÜD Product Service GmbH. She is responsible for strategic planning, political developments and the growing role of TÜV SÜD in representing its interests against relevant authorities and organizations.
Ms. Hoekstra-van den Bosch has 20 years of experience as a pharmaceutical and medical device regulator in the Dutch government. She subsequently served on the Medicines Evaluation Board, the Ministry of Health and the CCMO (Central Committee on Research Involving Human Subjects). She has represented the Netherlands at European and international level, e.g. in the EU Council Working Party on Medical Devices, the MDEG (EU Medical Devices Expert Group) and the GHTF (Global Harmonization Taskforce).
Ms. Hoekstra-van den Bosch was in charge of European regulation at Philips, where she was head and expert on EU regulations and standards for medical devices and pharmaceuticals at corporate level, as well as being involved in Philips' EU MDR/IVDR implementation program. In addition, she has served as Vice Chair of the EU Regulatory Focus Group and Chair of the Clinical Working Group in COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry) and as a member of the Regulatory Affairs Committee at MedTech Europe.
In addition to leading the regulatory strategy at TÜV SÜD in the area of Medical Health Services, she is active as a representative of TÜV SÜD and other Notified Bodies in several regulatory working groups at European level. In April 2020 she was elected Vice President of Team-NB (The European Association Medical devices of Notified Bodies), the European Association of Notified Bodies. She has a long track record in global professional organisations – DIA (Drug Information Association) and RAPS (Regulatory Affairs Professionals Organisation) – and is a regular speaker and faculty member at educational conferences on regulatory topics. She is a Fellow of RAPS since 2015 and was elected to the global board of RAPS in 2020.
Ms. Hoekstra-van den Bosch was trained as a pharmacist and holds a PharmD from the University of Leiden.
TÜV SÜD Product Service GmbH has around 1,100 employees. The services provided by TÜV SÜD Product Service GmbH cover with testing and certification services a wide range of customers, from textiles, toys, household appliances and electronic products to food, complex medical devices, industrial machinery, high-performance batteries and system components for manufacturing, the energy industry, the automotive industry, railway technology and aerospace.
Press-contact: Dirk Moser-Delarami
Bosnia and Herzegovina