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: email@example.com