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.
While based in Maidenhead, you would need to travel to the Oxford site twice a week.
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.
Experience and Skills Required
* 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.
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