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- Tasks: Lead regulatory affairs, ensuring compliance and successful product registrations.
- Company: Join GBUK Group, a thriving medical device company focused on patient care.
- Benefits: Hybrid work, professional development, and a chance to impact patient safety.
- Why this job: Make a real difference in healthcare while advancing your career.
- Qualifications: Degree in science or engineering, with regulatory experience in medical devices.
- Other info: Collaborative environment with opportunities for growth and meaningful contributions.
The predicted salary is between 36000 - 60000 £ per year.
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.
Regulatory Affairs Manager in Selby employer: GBUK
Contact Detail:
GBUK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager in Selby
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical devices sector and let them know you're on the hunt for a Regulatory Affairs Manager role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory standards like MDD, MDR, and ISO 13485. Show us that you’re not just familiar with these regulations but can also discuss how you've applied them in past roles.
✨Tip Number 3
Don’t forget to showcase your leadership skills! As a Regulatory Affairs Manager, you’ll be leading a team, so be ready to share examples of how you’ve successfully managed projects and motivated your team in previous positions.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows us you’re genuinely interested in joining GBUK Group and making a difference in patient care.
We think you need these skills to ace Regulatory Affairs Manager in Selby
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your relevant experience in regulatory compliance and project management, and don’t forget to mention any specific regulations you’ve worked with, like MDR or ISO standards.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your skills align with our mission at GBUK Group. Be sure to mention any specific achievements that demonstrate your ability to manage regulatory processes effectively.
Showcase Your Team Leadership Skills: Since this role involves managing a team, make sure to highlight your leadership experience. Talk about how you've successfully led teams in the past, managed workloads, and ensured compliance with regulations. We love seeing examples of collaboration!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at GBUK Group!
How to prepare for a job interview at GBUK
✨Know Your Regulations
Familiarise yourself with the key regulations and standards relevant to the medical devices sector, such as MDD, MDR, and ISO 13485. Being able to discuss these confidently will show that you’re not just knowledgeable but also passionate about regulatory affairs.
✨Showcase Your Leadership Skills
As a Regulatory Affairs Manager, you'll be leading a team. Prepare examples of how you've successfully managed teams in the past, focusing on planning, scheduling, and achieving deadlines. Highlight your experience in setting objectives and conducting appraisals.
✨Prepare for Cross-Functional Collaboration
This role involves working closely with various departments like R&D and Clinical Affairs. Think of specific instances where you've collaborated across functions to achieve a common goal. This will demonstrate your ability to work well in a team-oriented environment.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions ready about the company's regulatory strategies or upcoming projects. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
