At a Glance
- Tasks: Lead the EU regulatory strategy for a new Class III medical device and manage project activities.
- Company: Join a globally recognised healthcare company known for innovation and excellence.
- Benefits: Competitive salary, career progression, and the chance to work on impactful projects.
- Other info: High-impact role with excellent growth potential in a supportive international environment.
- Why this job: Be at the forefront of medical device regulation and make a real difference in healthcare.
- Qualifications: Experience in regulatory affairs for medical devices and strong knowledge of EU MDR 2017/745.
The predicted salary is between 60000 - 80000 £ 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 a brand new 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.
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 is centred on regulatory project leadership rather than line management. While there is no direct people management initially, the scope and visibility of the programme offers long-term progression potential.
To be successful as the new Regulatory Affairs Manager, you will bring proven experience leading EU regulatory strategy for Class III medical devices, ideally within a structured global organisation. You will be confident defining approval pathways under MDR 2017/745, comfortable operating at project leadership level across R&D, Clinical and global Regulatory teams, and experienced in managing Notified Body interactions. You will combine technical depth with the ability to influence stakeholders, manage complex timelines and take ownership of a high-visibility regulatory programme from concept through to approval.
- 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. Demonstrated leadership of regulatory strategy for new product development programmes is essential. Strong working knowledge of EU MDR 2017/745 and associated regulatory frameworks. 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 /Senior Manager in Witney employer: Cure Talent
As a leading global medical device organisation, we pride ourselves on fostering a dynamic work culture that champions innovation and regulatory excellence. Our commitment to employee growth is evident through our structured career progression opportunities and collaborative environment, where you will play a pivotal role in shaping the future of healthcare technology. Join us in a location that not only offers a vibrant professional landscape but also supports a healthy work-life balance, making it an exceptional place to advance your career in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager /Senior Manager in Witney
✨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 recent developments in medical devices. We recommend practising common interview questions with a friend to boost your confidence.
✨Tip Number 3
Showcase your project management skills! Be ready to discuss specific examples where you’ve led regulatory strategies or managed complex timelines. We want to see how you take ownership of projects.
✨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 Regulatory Affairs Manager /Senior Manager in Witney
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 medical devices and your knowledge of EU MDR 2017/745. 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 role. Share specific examples of your past successes in regulatory strategy and project management. Let us know what makes you tick!
Showcase Your Leadership Skills:Even though this role isn't about direct people management, we want to see your leadership qualities. Talk about how you've led projects or influenced teams in the past. Show us that you can drive regulatory strategies effectively!
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 any important updates. 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 regulations before your interview. Be ready to discuss how these regulations apply to Class III medical devices and share examples of how you've navigated regulatory pathways in the past.
✨Showcase Your Project Leadership Skills
Since this role focuses on regulatory project leadership, prepare to highlight your experience in managing complex timelines and leading cross-functional teams. Think of specific projects where you took ownership and drove success, and be ready to discuss them in detail.
✨Prepare for Stakeholder Management Questions
Expect questions about how you influence stakeholders and manage interactions with Notified Bodies. Have examples ready that demonstrate your ability to communicate effectively and build relationships across different teams, especially in a global context.
✨Align Your Experience with Their Needs
Tailor your responses to align with the job description. Emphasise your proven experience in regulatory affairs for medical devices and how it fits with their focus on innovation and regulatory excellence. Show them you understand their business and how you can contribute to their success.
