At a Glance
- Tasks: Lead the EU regulatory strategy for a new Class III medical device.
- Company: Global medical device organisation with a strong innovation pipeline.
- Benefits: Competitive salary, career progression, and a dynamic work environment.
- Other info: High-impact role with opportunities for growth in a well-resourced international setting.
- Why this job: Make a real impact in healthcare by driving regulatory excellence.
- Qualifications: Experience in regulatory affairs for Class III medical devices is essential.
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 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. 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.
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. If you would like to discuss this opportunity in confidence, we would welcome a conversation.
Regulatory Affairs Lead. Job in Curbridge LilyLifestyle Jobs employer: United Cerebral Palsy of Georgia
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, a collaborative environment, and the chance to work on cutting-edge technologies that make a real difference in healthcare. Located in Curbridge, our team enjoys a supportive atmosphere that encourages ownership and strategic thinking, making it an ideal place for those looking to advance their careers in regulatory affairs.
Contact Details:
United Cerebral Palsy of Georgia Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Lead. Job in Curbridge LilyLifestyle Jobs
✨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 leadership skills! Be ready to discuss specific examples where you’ve led regulatory strategies or managed complex projects. We want to see how you can take ownership of high-visibility programmes.
✨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 Lead. Job in Curbridge LilyLifestyle Jobs
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience with Class III medical devices and EU regulatory strategy. We want to see how your background aligns with the role, 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 position. Share specific examples of your leadership in regulatory strategy and how you’ve successfully navigated the EU MDR 2017/745.
Showcase Your Technical Knowledge:We’re looking for someone with a strong grasp of regulatory frameworks and Notified Body interactions. Make sure to include any relevant certifications or training that demonstrate your expertise in these areas. It’ll help us see your technical depth!
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. Plus, it makes the whole process smoother for everyone involved!
How to prepare for a job interview at United Cerebral Palsy of Georgia
✨Know Your Regulations Inside Out
Make sure you’re well-versed in EU MDR 2017/745 and the specific requirements for Class III medical devices. Brush up on your knowledge of regulatory pathways and be ready to discuss how you’ve navigated these in past roles.
✨Showcase Your Project Leadership Skills
Prepare examples that highlight your experience in leading regulatory strategies and managing complex timelines. Be ready to explain how you’ve successfully collaborated with R&D, Clinical Affairs, and global Regulatory teams in previous projects.
✨Engage with Notified Body Interactions
Since this role involves managing interactions with Notified Bodies, think of specific instances where you’ve effectively communicated and negotiated with them. This will demonstrate your ability to handle high-stakes regulatory discussions.
✨Demonstrate Your Technical Depth
Be prepared to discuss technical documentation, risk management, and clinical strategy. Show how your scientific or engineering background supports your regulatory expertise, and don’t shy away from diving into the details during the interview.
