Our client, a rapidly growing medical device consultancy are looking for a Regulatory Affairs Consultant to join their team. They provide consulting services to start-ups and small to medium- sized medical device manufacturers seeking to import medical devices into the EU.To provide regulatory support to other members of the team and Managing Director when requested.
- 100% remote working!!
- To review and assess CE/UKCA Technical Files to ensure compliance to current EU or UK Medical Device Regulations.
- Working knowledge of ISO 13485 & MDD/MDR & IVDR
- Responsible for effectiveness of UKRP Team. Manage sub-ordinates, develop team to ensure their training needs are met.
- Provide guidance/advice to UKRP clients to bring files into compliance to current EU or UK Medical Device Regulations.
- Oversea regular communication with clients to updates on regulatory changes.
- Technical file building from scratch (class 2 and 3 devices)
- Scientific background.
- Knowledge of the medical device industry and Regulatory Affairs.
- ISO 13485 QMS experience is ideal.
- Risk management ISO 14971 experience desired
- Experience in dealing with Regulatory bodies: EU Notified Bodies, EU Competent Authorities, UK Approved Bodies in an auditing capacity.
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.