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- Tasks: Lead the EU regulatory strategy for a new Class III medical device.
- Company: Join a globally recognised healthcare company with a strong innovation pipeline.
- Benefits: Competitive salary, career progression, and a dynamic work environment.
- Why this job: Make a real impact in the medical device industry and drive regulatory excellence.
- Qualifications: Experience in regulatory affairs for Class III devices and knowledge of EU MDR 2017/745.
- Other info: High-impact role with opportunities for growth in a well-resourced international setting.
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 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.
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 Manager in Witney employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager in Witney
✨Tip Number 1
Network like a pro! Reach out to industry professionals on LinkedIn or attend relevant events. We can’t stress enough how important it is to make connections that could lead to job opportunities.
✨Tip Number 2
Prepare for interviews by researching the company and its products. We recommend practising common interview questions and tailoring your answers to highlight your experience with Class III medical devices and EU regulatory strategies.
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work in regulatory affairs, especially any successful projects under MDR 2017/745. We want to see how you’ve made an impact in your past roles.
✨Tip Number 4
Don’t forget to follow up after interviews! A quick thank-you email can keep you top of mind. And remember, apply through our website for the best chance at landing that Regulatory Affairs Manager role!
We think you need these skills to ace Regulatory Affairs 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 our needs!
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 job description.
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 your previous roles, especially in regulatory settings.
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 from us!
How to prepare for a job interview at Cure Talent
✨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 integrated with R&D and Clinical teams to drive projects forward.
✨Engage with Stakeholders
Think about how you can demonstrate your ability to influence stakeholders. Prepare anecdotes that showcase your communication skills and how you’ve managed interactions with Notified Bodies and Competent Authorities.
✨Align with Company Values
Research the company’s mission and values, especially their focus on innovation and regulatory excellence. Be prepared to discuss how your personal values align with theirs and how you can contribute to their ongoing success.