Dr. Karin Lübbers
Personal statement
I love challenges! -and YES has a lot of these to offer; Our diverse customers range from small start-ups to multinational enterprises with different medical devices out of all risk classes. Creating good, pragmatic and cost-efficient solutions that fit the specific needs of our customers is the challenge my team and I face every day. Interdisciplinary, dedicated and with a lot of practical experience, we support or customers as advisory service providers in the field of Regulatory Affairs/Quality Management.
| 1994 | Graduation |
| 1994-2001 | Clinical & Regulatory Affairs Manager (responsible for the Quality Management System, Safety Officer for Medical Devices, auditor, international product registrations), Public Relations Manager, Polytech Silimed Europe GmbH, Dieburg (manufacturer of soft-tissue implants, class III) |
| 2002-2005 | Regulatory Affairs Manager (responsible for worldwide registrations of the medical devices of the Out Patient Market branch, auditor), B. Braun Melsungen AG, Melsungen (IVDs, single use devices, classes I, Im, Is, IIa, IIb) |
| 2005-2010 | Senior Manager Regulatory Affairs (team leader of the Regulatory Affairs team, Official Correspondent FDA, responsible for worldwide product registrations, internal lead auditor), Dräger Medical AG & Co. KG, Lübeck (mainly anaesthesia devices, ventilators, classes IIa, IIb) |
| Seit 2010 | Head (responsible for the division Medical Devices), Yes Medical Device Services GmbH, Friedrichsdorf (consulting Regulatory Affairs/Quality Management Medical Devices) |