Regulatory Affairs Manager

We’re Hiring: Regulatory Affairs Manager

Location: Woodland House, North Duffield, Selby, North Yorkshire

Company: GBUK Group | Medical Devices

Contract: Full-time | Hybrid

Are you looking for an opportunity to join a thriving, successful business whose continued growth and passion for enhancing patient care, means you can truly make a difference? Are you confident executing a regulatory strategy to the highest standard and ensuring the successful roll-out of new innovations and product changes?

If you enjoy a fast-paced role in which your work directly contributes to patient safety and you are passionate about regulatory affairs, read on… an exciting opportunity awaits!

About the role:

• As Regulatory Affairs Manager, you will be responsible for managing the Regulatory Affairs department under the leadership of the Head of Regulatory Affairs.
• Responsible for all company regulatory product registrations, certification and maintenance.
• Responsible for regulatory procedures and processes, regulatory systems and departmental ways of working.
• Responsible for the overall effective planning and scheduling of workload, tasks and priorities for the senior regulatory affairs associates (direct reports), regulatory affairs associates (indirect reports) and labelling coordinators (indirect reports).

Key Responsibilities:

• Lead the senior regulatory affairs associates (direct reports), regulatory affairs associates (indirect reports) and labelling coordinators (indirect reports), overseeing all team responsibilities and workload, effectively planning, scheduling and assigning work/projects in line with deadlines
• Perform and support with market research and regulatory strategies to achieve market registrations of current and new devices
• Ensuring compliance with all applicable regulations, standards and guidance’s, and adhering to GBUK SOPs
• Raise, review and complete actions as part of change control process.
• Work cross functionally with other departments such as but not limited to R&D, Quality affairs, Clinical Affairs, Marketing, Sales
• Review and provide input as necessary into R&D, marketing and clinical documentation and processes
• Review and completion of post market surveillance documentation and activities, lead by clinical affairs
• Communication with regulatory authorities and regulatory bodies
• Change notification tracking, writing and submission to regulatory bodies, and management of such through to approvals
• Communications with regulatory bodies and involvement in RTQ writing, review and submission, to achieve conformity assessment approval, and/or maintenance of CA mark
• Overall responsibility for maintaining the regulatory team tracker and ensuring all regulatory projects are planned and scheduled appropriately. Ensuring business critical projects (MDR, IVDR) and changes (CCRs) are implemented in a timely manner and achieved on time
• Ensuring compliance of product and product packaging, labelling, including instructions for use, product literature and any associated product claims, along with UDI compliance
• Oversee regulatory project leads for new product development and compliance projects

What you can bring to the role:

• Degree or equivalent certification in science related, medical, or engineering discipline.
• Project management and use of various databases and computer software tools
• The ability to assess all necessary and specific regulatory obligations as appropriate for the device, to ensure regulatory compliance
• Experience of regulatory body change notification and RTQ for regulatory dossiers
• Regulatory experience within the medical devices sector
• Working knowledge of the MDD, MDR, IVDD, IVDR, UK MDR, ISO 13485 and related ISO standards
• Experience in the Compilation, review, maintenance and regulatory body submission of Class I, IIa, IIb and III EU technical documentation for CE and/or UKCA marking
• Experience in the compilation, review, maintenance and submission of 510ks and of regulatory body communication
• Experience with Clinical Evaluation compilation and Risk Management implementation to applicable standards
• Experience of people management, having set departmental objectives and performed appraisals

Why Join GBUK Group?

You will be part of a growing, purpose-led organisation where your work directly impacts patient care and device safety. The role offers opportunities for professional development, cross-functional collaboration, and meaningful contribution to the future of GBUK’s medical device portfolio.

Equality:

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.