Well respected client in Germany requires a dynamic consultant to join the MDR project team. You will be responsible for all MDR related Regulatory tasks for their products, which have to be supported in the Swiss region.
The required activities include showing a Swiss Authorised Representative on all our product labelling, a national Swiss product registration and establishing an economic operator.
- Independent execution of the Regulatory activities (approving content) for the over label activities for the client
- Independent product registration for the client in the new national Swiss Regulatory framework
- Independent establishing of an economic operator in Switzerland regarding the required Regulatory activities,
- Elaborate Swiss Authorised Representative Agreement with cross functional teams and routing for final signature
- Supporting relevant SOP updates by reviewing initial draft, coordinating internal feedback, liaising with cross functions
- Knowledge on Swiss MDR regulations
- 2-4 Years Reg affairs Medical Devices
- MDD/MDR essential
- German would be a plus.
Please contact Phil Turner or email your resume for an immediate response