Medical Device Regulatory Associate
Clinical Life Sciences Pharmaceuticals
CY Partners have an exciting opportunity for a Medical Device Regulatory Associate to join an expanding innovative company based in Oxford.
As a Medical Device Regulatory Associate, you will play a critical role in successfully delivering innovative medical device projects. Sitting on the Project Team, you will work across a wide variety of projects delivering against agreed regulatory strategies.
Other responsibilities include:
·Working alongside the quality and technical leads write regulatory and quality documentation for submission.
·Prepare documentation for CE marking dossier
·Prepare for and attend meetings with Notified Bodies
·Co-ordinate external contractors and internal Medical Writers/technical experts assigned to the project
·Co-ordinate all device related technical questions ie biocompatibility, risk management, toxicology, usability, sterilization etc.
If you have experience in medical devices and working knowledge of MDR implementation, we would love to hear from you.
For further information please feel free to contact Helen at CY Partners on 0191 477 4733 or send your CV to [email protected]