Stephanie Horn, PhD F. Hoffmann - La Roche

Stephanie Horn has over 25 years of experience in Medical Device and Pharma industry. In her current role as regulatory manager and senior expert for Device & Combination Products at F. Hoffmann-La Roche AG (Switzerland) she is responsible for global registrations of devices and combination products and was responsible for the implementation of processes ensuring compliance with EU MDR, including MDR Article 117. For several years, she has been involved in regulatory policy, advocating for a balanced and proportionate regulatory and political framework for combined products.  Before her time with Roche Pharma, Stephanie worked with several medical device and IVD companies as well as with a Notified Body for medical devices. She is a Biologist by training and holds a PhD in Virology from Friedrich-Alexander University of Erlangen-Nuernberg.