Stephanie Goebel, Dipl. Ing. Roche/Genentech

Stephanie Goebel Senior Regulatory Program Director PTR Devices and Combination Products at Roche / Genentech Stephanie Goebel 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, Stephanie supported 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 at Roche / Genentech, Stephanie will support end-to-end management of device regulatory strategies and implementation as well as building respective inernal regulatory capabilities.