
is a medical engineer with more than 15 years of experience in medical devices and combination products. She worked as auditor, technical documentation reviewer (MDD and ISO 13485) as well as product specialist on Article 117 (MDR) for a notified body and was a member of the Team NB (European Association of Notified Bodies) working group on Article 117 (MDR). As consultant, shesupported clients in their transition to the MDR and/or quality system related activities though regulatory analysis, readiness audits/checks, document creation and personalized trainings. In her new role as Senior Regulatory Program Director PTR Devices and Combination Products at Roche / Genentech, Stephanie Göbel supports end-to-end management of device regulatory strategies and implementation as well as building respective inernal regulatory capabilities.