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 EMEA region and which require detail knowledge of MDR regulations and respective guidelines. Aim of the entire MDR project is to conduct the transition process from MDD to MDR.
- Create and submit the TechFiles for the Medical Device to the Notified Body.
- Independent writing of Technical documentation for the clients products and final document review before submission.
- Technical consultation on interpretation of MDR, MDCG or common specifications on request by the MDR project teams
- Independent review of the MDR compliance of all documents which are part of a Technical File, with a special focus on Regulatory documents like labelling, product classification or the main text of the technical documentation
- Contact point for Regulatory related audit questions for the MDR audits
- Independent review and test of the new Eudamed database
- 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