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.
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
Salary description
£85000.00 - £95000.00 per year