Regulatory Affairs Supervisor

**Regulatory Affairs Supervisor**

**Location: Cambridgeshire**

Are you looking for a new opportunity working for an established diagnostic company that develop, manufacture and market pioneering diagnostic products associated with food sensitivity and gut health. They are looking for a Regulatory Affairs Supervisorto join their team, working on a hybrid basis from their site in Cambridgeshire.

As the Regulatory Affairs Supervisor, you will be responsible for ensuring that the Regulatory Affairs (RA) function in the company performs to a level that allows the organisation to meet all its regulatory responsibilities.

Main Areas of Responsibility:

- Manage day-to-day Regulatory Affairs activities providing guidance and support to the Omega Diagnostics Regulatory Affairs team.
- Planning, coordination, and management of regulatory documentation activities.
- Review and compilation of Medical Device Files (such as Technical Files, DHF) for Omega Diagnostics products to ensure adequate 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 of Omega Diagnostics regulatory submissions to comply with regulatory authorities for registrations of products worldwide to gain marketing authorization.
- Notification to regulatory authorities, where applicable, of significant product changes to retain marketing authorization.
- To 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 material for Omega Diagnostics products, as required.
- 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.
- To ensure regulatory processes are followed and within required timeframes.
- Supporting 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 ODL's areas of cGMP and continual improvement in all aspects of the QMS.
- and post
- market IVD regulations, and submissions for global markets. You will have good analytical, organisational, critical thinking, and problem-solving skills. You will educated to degree level or equivalent.