Regulatory Affairs Manager – Medical Devices
We are partnered with a leading medical device company who are looking for a Regulatory Affairs Project Manager to come in for an initial 6 month period to lead a transition MDD -> MDR project. Specific information on the role is available if required.
The role can be located in Eastern France or Western Switzerland. If you’re looking for a new challenge, this will move very quickly with a view to move permanent available.
Manage update and maintenance of legacy technical documentation; propose and implement actions following GAP analysis with respect to MDD and MDR
Coordinate cross-functional activities regarding technical documentation (i.e. with R&D, Clinical Affairs)
Manage project team to update all technical files in the framework of MDR implementation
Ensure implementation of all required actions to update technical documentation
Prepare and manage product risk management meetings
Bachelors’ or Masters’ degree in Biomedical Engineering, Life Sciences, or equivalent
5 years’ experience in technical file management in an international MedTech environment
Strong background in Risk (EN ISO 14971), Usability Engineering (EN 62366), Biological Safety (ISO 10993-x)
Good knowledge of the European MDD and European MDR
Fluent English; French or German would be a plus