Regulatory Affairs Associate

Role:

Support the AR Manager in all tasks related to Authorised Representative activities and transition activities required to comply with the Medical Device Regulation.  Including:

  • Manage client relationships to ensure full visibility of required documentation and advise on regulatory topics.
  • Notification of first marketing activities as required in European territories.
  • Review of technical documentation to confirm compliance to MDD/MDR (where applicable).
  • Support of Vigilance reporting activities as required.
  • Drafting of periodic newsletters.

Experience and skills:

  • Knowledge of MDD/AIMDD and working understanding of MDR.
  • Previous employment to include manufacturer/Notified Body/Competent Authority for a minimum of 2 years.
  • Proficient spoken and written English, another European language would be beneficial but not essential.
  • Ability to work independently and self-directed.
  • Excellent communication skills with team members, clients and regulatory authorities.

Largely home-based position with meetings in Worcestershire/Warwickshire and possibly Paris as required.

Salary will be dependent upon experience.

 

If you are interested to join MedPass, please send your resume to the following address: juliedelrue@medpass.org