Here at SRG, we are proud to be partnering with an establish diagnostic company that develop, manufacture and market pioneering diagnostic products associated with food sensitivity and gut health. They are looking for a Regulatory Affairs Associate and Specialist to join their team, working on a hybrid basis from their site in Cambridgeshire.
In these roles, 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.
As the ideal candidate, you will have between 1 and 5 years' experience within the IVD/medical device field in a regulatory affairs role along with people management experience (for the supervisor). You will have working knowledge of domestic and international regulatory affairs guidelines and knowledge of pre- 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.
Carbon60, Lorien, SRG - the Impellam Group STEM Portfolio is acting as an Employment Business in relation to this vacancy.
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