At a Glance
- Tasks: Lead the EU regulatory strategy for a new Class III medical device under MDR.
- Company: Global leader in medical devices with a strong focus on innovation.
- Benefits: Competitive salary, career progression, and the chance to work on impactful projects.
- Other info: High-impact role with opportunities for growth in a well-resourced international setting.
- Why this job: Shape the future of healthcare by driving regulatory excellence in a dynamic environment.
- Qualifications: Proven experience in regulatory affairs for medical devices and strong knowledge of EU regulations.
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.
Senior Manager/Director of Regulatory Affairs in Witney employer: Cure Talent
As a leading global medical device organisation, we pride ourselves on fostering a dynamic and inclusive work culture that prioritises innovation and regulatory excellence. Our employees benefit from extensive professional development opportunities, competitive compensation packages, and the chance to work on groundbreaking technologies that make a real difference in healthcare. Join us in our state-of-the-art facilities, where your expertise will be valued, and your career can flourish within a supportive and collaborative environment.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager/Director of Regulatory Affairs 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 your successes and how you overcame challenges.
✨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 Senior Manager/Director of Regulatory Affairs in Witney
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Regulatory Affairs Manager. 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 that relate to the position.
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 influenced stakeholders and led projects in the past. This will help us understand your approach to driving regulatory strategies.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and keep track of it. Plus, it shows you’re keen on joining our team!
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. Be prepared to discuss how these regulations impact the approval pathways for Class III medical devices. Showing that you can navigate these complexities will impress your interviewers.
✨Demonstrate Project Leadership Skills
Since this role focuses on regulatory project leadership, come ready with examples of past projects where you led regulatory strategies. Highlight how you managed timelines and collaborated with R&D and Clinical teams to achieve successful outcomes.
✨Prepare for Stakeholder Management Questions
Expect questions about how you influence stakeholders and manage interactions with Notified Bodies. Think of specific instances where you successfully navigated complex stakeholder dynamics and how you ensured alignment across teams.
✨Showcase Your Technical Depth
Be ready to discuss your technical knowledge related to regulatory affairs in medical devices. Prepare to explain how you've contributed to design, risk management, and compliance with ISO 13485 in previous roles, as this will demonstrate your expertise and readiness for the position.
