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- Tasks: Lead regulatory strategy for a new Class III medical device from development to approval.
- Company: Global leader in medical technology focused on innovation.
- Benefits: Competitive salary, excellent benefits, and relocation support.
- Other info: Join a team where regulatory expertise is a core strategic function.
- Why this job: Shape the future of medical devices and influence at a senior level.
- Qualifications: 8+ years of Regulatory Affairs experience in medical devices.
The predicted salary is between 70000 - 90000 £ 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.
Senior Manager/Director of Regulatory Affairs employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager/Director of Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those who have experience with Class III devices. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU MDR and CE Marking processes. We want you to be able to discuss how you would shape regulatory strategies for complex devices confidently.
✨Tip Number 3
Showcase your strategic thinking skills! During interviews, share examples of how you've navigated regulatory challenges in the past. This will demonstrate your ability to influence at a senior level and deliver pragmatic solutions.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Senior Manager/Director of Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in regulatory affairs, especially with Class III devices. We want to see how your background aligns with the strategic role we're offering, so don’t hold back on showcasing relevant achievements!
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 position. We love seeing passion and clarity, so make sure to express your enthusiasm for shaping regulatory pathways and driving innovation.
Showcase Your Strategic Thinking: In your application, highlight examples where you've successfully navigated complex regulatory challenges. We’re looking for someone who can influence at a senior level, so share those stories that demonstrate your ability to think strategically and deliver results.
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 this exciting opportunity. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines related to Class III medical devices. Familiarise yourself with the EU MDR and CE Marking processes, as you'll need to demonstrate your expertise in shaping regulatory pathways during the interview.
✨Showcase Your Strategic Thinking
Prepare examples of how you've successfully defined and led regulatory strategies in previous roles. Be ready to discuss specific challenges you faced and how you navigated ambiguity to deliver innovative solutions. This will show that you can think critically and strategically.
✨Collaboration is Key
Since this role involves working closely with cross-functional teams, be prepared to talk about your experience collaborating with R&D, Clinical, and Quality teams. Highlight instances where your regulatory insights influenced product development and led to successful outcomes.
✨Be Ready for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills and ability to identify regulatory risks. Practice articulating your thought process and the pragmatic solutions you would propose, as this will demonstrate your capability to handle real-world challenges.