Overview
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.
Responsibilities
- Define and own the EU regulatory strategy for a new Class III device under MDR.
- Lead regulatory project management activities, integrating with global Regulatory Affairs, 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.
#J-18808-Ljbffr…