Ra Consultant

5 days ago


West Midlands Region, United Kingdom Real Staffing Full time

**Regulatory Affairs Consultant - (Medical Devices)**

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 devicesinto the EU.

**Position**
- Review and assess CE/UKCA Technical Files to ensure compliance to current EU or UK Medical Device Regulations.
- Lead the UKRP Team and be Line Manager for both UKRP Co-Ordinator and Junior Business Administrator.
- To provide medical device Regulatory advice.
- Fully support the Managing Director.

**Key Responsibilities**:

- To provide regulatory support to other members of the team and Managing Director when requested.
- 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.
- To review and assess CE/UKCA Technical Files to ensure compliance to current EU or UK Medical Device Regulations.
- 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.

**About You**:

- Ideally a Scientific background.
- Knowledge of the medical device industry and Regulatory Affairs.
- ISO 13485 QMS experience is ideal.
- Risk management ISO 14971 experience.
- Experience in dealing with Regulatory bodies: EU Notified Bodies, EU Competent Authorities, UK Approved Bodies in an auditing capacity.

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales



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