Elizabeth GfoellerCorporate Director, Regulatory Affairs at MED-ELAdvisor
Profile
Elizabeth Gfoeller is the Corporate Director of Regulatory Affairs of MED-EL, an EU medical device manufacturer headquartered in Innsbruck, Austria.
MED-EL is the global innovation leader in hearing loss solutions. To date, MED-EL’s implantable and non-implantable systems marketed in over 123 markets have restored hearing to more than 200,000 individuals worldwide.
Joining MED-EL in 2006, she currently leads the Corporate Regulatory Affairs function responsible for over 123 markets globally for product licensing, registrations, re-certifications, post-market vigilance activities, regulatory strategies for new product developments and related compliance activities internally within MED-EL and externally to new and changed regulations and standards.
She acts as the responsible person for communication with regulatory agencies and engages in lobbying activities. Previously Elizabeth worked in the mobile telecommunications sector in regulatory compliance and data protection in Vodafone Ireland. Her educational background is in social sciences, with her graduate and post graduate studies in Sociology completed at the University of the Witwatersrand, South Africa where she was active for many years as a lecturer and social researcher.
Agenda Sessions
EU MDR: Timelines, Transitions and Tribulations
, 08:40View SessionChairperson’s Opening Remarks: Software and AI for Medical Devices & IVDs
, 08:30View SessionChairperson’s Afternoon Remarks: Software and AI for Medical Devices & IVDs
, 14:10View SessionBest Practices in Enterprise Evidence Management
, 14:15View Session