Regulatory Affairs Supervisor

2 weeks ago

Ely, United Kingdom Real Staffing Full time

Our client is an international medical device company passionate about improving lives around the world by accurately informing health decisions. Drawing on over 30 years' experience, they develop, manufacture and market pioneering diagnostic products. Theyuse advanced diagnostic technology and offer lab services to ISO 13485 etc.

Supported by the Head of Department the Regulatory Affairs Supervisor will manage the Regulatory Affairs (RA) function ensuring it performs to a level that allows the organisation to meet all its regulatory responsibilities.

**Responsibilities**:

- The Regulatory Affairs Supervisor will manage day-to-day Regulatory Affairs activities providing guidance and support to the team.
- Plan, coordinate, and manage regulatory documentation activities.
- Review and compilation of Medical Device Files in compliance with regulations.
- Preparation of documentation in support of regulatory function, i.e., post-market surveillance reports, risk management plans/reports, and others, as required.
- Preparation of documentation in support registrations of products worldwide to gain marketing authorisation.
- Notification to regulatory authorities, where applicable, of significant product changes to retain marketing authorisation.
- The Regulatory Affairs Supervisor will liaise with partners and regulatory authorities to support regulatory submissions and vigilance activities.
- Review and approve product labelling, including instructions for use, container labels, packaging artwork, promotional and training materials
- Review and approval of product development verification protocols and reports.
- Implementation and maintenance of a UDI system.
- Maintenance of Regulatory procedures to ensure continued compliance.
- Responsible for post-market surveillance activities.
- The Regulatory Affairs Supervisor will support internal and external audits to represent Regulatory Affairs positions and processes.
- Assess changes in regulations and determine their impact.
- Lead, mentor, and train team members as required.
- To be involved in areas of cGMP and continual improvement of the QMS.

**Education/Skills**:

- Regulatory Affairs in medical Device or Life Sciences
- People management
- Performance review, training or development experience
- Maintain compliance with Health & Safety policies and procedures
- Maintain compliance with QMS policies and procedures.

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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