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- Tasks: Lead the EU regulatory strategy for a new Class III medical device.
- Company: Global leader in medical devices with a strong focus on innovation.
- Benefits: Competitive salary, career growth, and a chance to impact healthcare.
- Why this job: Shape the future of medical technology and ensure product success.
- Qualifications: Experience in Regulatory Affairs, especially with Class III devices.
- Other info: Join a well-resourced international team and thrive in a dynamic environment.
The predicted salary is between 36000 - 60000 £ per year.
Cure Talent are delighted to be partnered with a global medical device organisation recognised as one of the most established and successful healthcare companies in the world. With a diverse international footprint and a strong pipeline of innovation, the business continues to invest heavily in next-generation technologies and regulatory excellence.
We have an opportunity for a Regulatory Affairs Manager to lead the EU Regulatory Strategy for a brand new Class III medical device. This is a strategically significant role within a highly experienced global regulatory function.
Responsibilities- Define and own the EU regulatory strategy for a new Class III device under MDR.
- Lead regulatory project management activities, integrating with global Regulatory Affairs, 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.
If you would like to discuss this opportunity in confidence, we would welcome a conversation.
Regulatory Affairs Manager employer: Cure Talent Ltd
Contact Detail:
Cure Talent Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs 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 Class III devices. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise.
✨Tip Number 3
Showcase your leadership skills! Be ready to share examples of how you've led regulatory strategies in the past. We want to see how you can take charge and drive success in this new role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re here to help you every step of the way, so let’s get you that Regulatory Affairs Manager position!
We think you need these skills to ace Regulatory Affairs 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 your knowledge of EU MDR 2017/745. We want to see how your background aligns with the responsibilities outlined in the job description.
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 you can contribute to our team. Be sure to mention any relevant projects you've led and how they relate to the new Class III device.
Showcase Your Leadership Skills: Since this role involves leading regulatory strategy, make sure to highlight your leadership experience. Share examples of how you've successfully managed regulatory projects and collaborated with cross-functional teams. We love seeing candidates who can take charge!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, it’s super easy!
How to prepare for a job interview at Cure Talent Ltd
✨Know Your Regulations
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 Leadership Skills
Prepare examples of how you've led regulatory strategies for Class III devices in the past. Highlight specific projects where you integrated with cross-functional teams, as this will demonstrate your ability to manage complex regulatory environments effectively.
✨Understand the Company’s Vision
Research the company’s pipeline of innovation and their approach to regulatory excellence. This will help you align your answers with their goals and show that you’re genuinely interested in contributing to their success.
✨Prepare for Scenario Questions
Think about potential challenges you might face in this role, such as managing Notified Body interactions or ensuring compliance with ISO 13485. Prepare thoughtful responses that showcase your problem-solving skills and strategic thinking.
