Stephanie Göbel Dipl-Ing FH Roche / Genentech

Stephanie is a Senior Regulatory Program Director for medical devices and combination products at Roche Pharma, with 18+ years of experience in the implementation of legislative acts or standards (e.g., MDR / ISO 13485), QMS remediation, and technical documentation review/auditing at global pharmaceutical and medical device companies, as well as at a notified body. She has successfully combined her background as a Medical Engineer with extensive experience in the device development, regulatory, and quality fields. Stephanie started her career in a Swiss-based start-up for resorbable implants used in various body regions (e.g., hand, spine) as an R&D engineer, where she was project lead as well as involved in planning of biomechanical and clinical studies, setup of quality management, and CE certification relevant documentation. Afterwards, Stephanie moved to in vitro diagnostic medical devices and joined Roche Diagnostics as Quality Manager, QA Instrumentations – responsible for management of deviations, changes, and risk management documentation. She worked as an auditor, technical documentation reviewer (MDD and ISO 13485), as well as product specialist on Article 117 (MDR) for certification / notified body TUV SUD Product Service GmbH, and was a member of the Team NB (European Association of Notified Bodies) working group on Article 117 (MDR). As a consultant, Stephanie supported clients in their transition to the MDR and/or quality system-related activities through regulatory analysis, readiness audits/checks, document creation, and personalized training. In her recent role at Roche / Genentech, Stephanie supports end-to-end management of device regulatory strategies and implementation, regulatory policy activities, as well as building respective internal regulatory capabilities.