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- Tasks: Lead regulatory strategy for innovative Class III medical devices from development to approval.
- Company: Global leader in medical technology focused on innovation and advanced devices.
- Benefits: Competitive salary, excellent benefits, and relocation support available.
- Other info: Join a dynamic team where regulatory expertise is valued as a core function.
- Why this job: Shape the future of medical devices and make a real impact in healthcare.
- Qualifications: 8+ years of Regulatory Affairs experience in medical devices required.
The predicted salary is between 60000 - 80000 £ per year.
We are supporting a global leader in medical technology as they continue to invest heavily in innovation within their advanced device portfolio. As part of a critical, high-visibility programme, we are seeking a senior Regulatory Affairs professional to lead strategy for a new Class III medical device currently in development.
The Opportunity
This is a purely strategic role, focused on shaping the regulatory pathway of a novel, complex device from development through to approval. You will take full ownership of regulatory strategy, driving the route to CE Marking under EU MDR and acting as the regulatory authority within a cross-functional programme. This is a role for someone who can influence at a senior level, navigate ambiguity, and define innovative approaches to regulatory approval.
- Define and lead the Regulatory Strategy for a new Class III device
- Embed regulatory expertise into product development from early-stage through to approval
- Identify regulatory risks and deliver strategic, pragmatic solutions
- Collaborate closely with R&D, Clinical, Quality and global regulatory teams
- Support alignment with broader global regulatory strategies
8+ years’ Regulatory Affairs experience within medical devices. Be part of an organisation where regulatory is viewed as a core strategic function. Relocation support is available for the right candidate.
Regulatory Affairs Manager /Senior Manager employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager /Senior Manager
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU MDR and CE Marking processes. We want you to showcase your expertise and strategic thinking, so practice articulating your thoughts on navigating regulatory pathways.
✨Tip Number 3
Don’t just apply; engage! When you submit your application through our website, follow up with a friendly email expressing your enthusiasm for the role. It shows initiative and keeps you on their radar.
✨Tip Number 4
Stay updated on industry trends and regulatory changes. We recommend subscribing to relevant newsletters or joining forums. This knowledge will not only help you in interviews but also position you as a thought leader in the field.
We think you need these skills to ace Regulatory Affairs Manager /Senior Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience with Class III devices and any strategic roles you've held. We want to see how your background aligns with the job description!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this strategic role. Share specific examples of how you've influenced regulatory pathways in the past, and don’t forget to show your passion for innovation in medical technology.
Showcase Your Collaboration Skills: Since this role involves working closely with R&D, Clinical, and Quality teams, make sure to highlight your collaboration skills. We love seeing examples of how you've successfully worked in cross-functional teams to achieve regulatory goals.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensure it gets the attention it deserves. Don’t miss out on this exciting opportunity!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations, especially around Class III devices and CE Marking under EU MDR. Being able to discuss specific regulatory pathways and how they apply to the role will show that you're not just familiar with the basics but are ready to take ownership of the strategy.
✨Showcase Your Strategic Thinking
Prepare examples of how you've previously shaped regulatory strategies or navigated complex approval processes. Use the STAR method (Situation, Task, Action, Result) to structure your responses, highlighting your ability to influence at a senior level and deliver innovative solutions.
✨Collaboration is Key
This role involves working closely with various teams like R&D, Clinical, and Quality. Be ready to discuss how you've successfully collaborated in cross-functional environments before. Think of specific instances where your regulatory expertise helped bridge gaps between departments.
✨Embrace Ambiguity
Regulatory affairs can often be unpredictable. Prepare to talk about times when you've had to navigate uncertainty and how you approached problem-solving in those situations. Showing that you can thrive in ambiguity will set you apart as a candidate who can lead in challenging circumstances.