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 medical device organisation with a strong innovation pipeline.
- 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: Make a real difference in healthcare by driving regulatory success for innovative products.
- Qualifications: Proven experience in regulatory affairs for medical devices and 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.
Compliance 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 prioritises innovation and regulatory excellence. Our employees benefit from extensive growth opportunities within a supportive environment, where they can take ownership of impactful projects and collaborate with top-tier professionals across the globe. Located in a vibrant area, our company not only offers competitive benefits but also a chance to be part of a mission-driven team dedicated to advancing healthcare technology.
StudySmarter Expert Advice🤫
We think this is how you could land Compliance 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 device regulations. We want you to walk in with confidence and show them you’re the expert they need!
✨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 love hearing about real experiences that highlight your capabilities.
✨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 interview!
We think you need these skills to ace Compliance Manager/Senior Manager in Witney
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Compliance Manager/Senior Manager role. Highlight your experience with EU regulatory strategies and Class III medical devices, as this will show us you’re the right fit for the job.
Craft a Compelling Cover Letter:Your cover letter should tell us why you’re passionate about regulatory affairs and how your background aligns with our needs. Use specific examples from your past experiences to demonstrate your expertise in managing regulatory pathways.
Showcase Your Leadership Skills:Even though this role isn’t about direct people management, we want to see your project leadership skills shine through. Share instances where you’ve led teams or projects successfully, especially in a regulatory context.
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 in our global organisation.
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. Being able to discuss specific pathways and requirements for Class III medical devices will show that you're not just familiar with the rules, but that you can apply them effectively.
✨Showcase Your Project Leadership Skills
Prepare examples of how you've successfully led regulatory projects in the past. Highlight your ability to manage timelines, coordinate with cross-functional teams, and influence stakeholders. This will demonstrate that you have the experience needed for this high-visibility role.
✨Understand the Company’s Product Pipeline
Research the company’s current and upcoming products, especially in the Class III category. Being knowledgeable about their innovations will help you align your answers with their strategic goals and show genuine interest in their work.
✨Prepare for Notified Body Interactions
Think about your experiences with Notified Bodies and be ready to discuss how you've managed those interactions. This is crucial for the role, so showcasing your understanding of the process and any challenges you've overcome will set you apart.
