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- Tasks: Lead the EU regulatory strategy for a groundbreaking Class III medical device.
- Company: Join a globally recognised organisation at the forefront of medical innovation.
- Benefits: Competitive salary, career progression, and the chance to make a real impact.
- Other info: Dynamic role with opportunities for growth in a well-resourced international environment.
- Why this job: Shape the future of healthcare by driving regulatory success for new products.
- Qualifications: Experience in Regulatory Affairs, especially with Class III devices, is essential.
The predicted salary is between 60000 - 75000 £ per year.
We have an opportunity for a Regulatory Affairs Manager to lead the EU Regulatory Strategy for a brand new Class III medical device. This strategically significant role is within a highly experienced global regulatory function.
As the Regulatory Affairs Manager, you will define and drive the EU regulatory pathway under MDR 2017/745 for a new product programme. You will lead regulatory strategy development from early-stage development through to submission and approval, ensuring alignment with global regulatory, clinical and R&D teams. This position focuses on regulatory project leadership rather than line management. Although there is no direct people management initially, the scope and visibility of the programme offer long-term progression potential.
Key Responsibilities- Define and own the EU regulatory strategy for a new Class III device under MDR.
- Lead regulatory project management activities, integrating with global RA, Clinical Affairs and R&D teams.
- Develop and maintain regulatory plans aligned to product development milestones.
- Lead Notified Body strategy and manage regulatory interactions.
- Provide regulatory input into design, risk management, clinical strategy and technical documentation.
- Support audits and ensure ongoing compliance with ISO 13485 and applicable regulations.
- Proven experience within Regulatory Affairs in medical devices.
- Direct experience with Class III devices is essential.
- Demonstrated leadership of regulatory strategy for new product development programmes is essential.
- Strong working knowledge of EU MDR 2017/745 and associated regulatory frameworks.
- Experience interacting with Notified Bodies and Competent Authorities.
- Experience across additional regions such as US or other international markets is highly desirable but not essential.
- Degree in a relevant scientific or engineering discipline.
This is a high-impact opportunity within a globally recognised organisation where regulatory strategy sits at the heart of product success. It will suit a regulatory professional who enjoys ownership, structured project delivery and operating within a large, well-resourced international environment.
Regulatory Affairs Manager in London employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager in London
✨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 2017/745 and Class III devices. We recommend creating a cheat sheet of key points to discuss, so you can showcase your expertise confidently.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest checking out our website for tailored opportunities that fit your skills in regulatory affairs.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We believe showing appreciation for the opportunity can set you apart from other candidates.
We think you need these skills to ace Regulatory Affairs Manager in London
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 job description, so don’t be shy about showcasing relevant projects and 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 the Regulatory Affairs Manager role. We love seeing passion and clarity, so make sure to connect your experience with our needs directly.
Showcase Your Regulatory Knowledge: Since this role focuses on EU regulatory pathways under MDR 2017/745, be sure to demonstrate your knowledge in this area. We’re looking for candidates who can clearly articulate their understanding of the regulations and how they apply to product development.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s super easy!
How to prepare for a job interview at Cure Talent
✨Know Your Regulations Inside Out
Make sure you brush up on the EU MDR 2017/745 and any other relevant regulations. Being able to discuss these confidently will show that you're not just familiar with the rules, but that you can apply them strategically in your role.
✨Showcase Your Project Management Skills
Prepare examples of how you've led regulatory projects in the past. Highlight your ability to integrate with global teams and manage timelines effectively. This will demonstrate your readiness for the project leadership aspect of the role.
✨Engage with Notified Bodies Knowledge
Familiarise yourself with the process of interacting with Notified Bodies. Be ready to discuss your experiences or strategies for managing these relationships, as this is a key part of the role.
✨Align with Company Values
Research the company’s mission and values. During the interview, relate your personal values and professional goals to theirs. This alignment can set you apart as a candidate who is not only qualified but also a great cultural fit.