- Regulatory Affairs Manager – Development Strategy (Class III Devices)
- West Oxford, UK (100% On-Site)
- Competitive Salary + Excellent Benefits + Relocation Support
We are supporting a global leader in medical technology as they continue to invest heavily in innovation within their advanced device portfolio. As part of a critical, high-visibility programme, we are seeking a senior Regulatory Affairs professional to lead strategy for a new Class III medical device currently in development.
The Opportunity
This is a purely strategic role, focused on shaping the regulatory pathway of a novel, complex device from development through to approval. You will take full ownership of regulatory strategy, driving the route to CE Marking under EU MDR and acting as the regulatory authority within a cross-functional programme. This is a role for someone who can influence at a senior level, navigate ambiguity, and define innovative approaches to regulatory approval.
Key Responsibilities
- Define and lead the Regulatory Strategy for a new Class III device
- Own and deliver CE Marking activities under EU MDR, including submission pathways
- Drive the creation, review and defence of Technical Documentation / Technical Files (Annex II & III)
- Lead all interactions with Notified Bodies, including strategy discussions and submissions
- Embed regulatory expertise into product development from early-stage through to approval
- Identify regulatory risks and deliver strategic, pragmatic solutions
- Collaborate closely with R&D, Clinical, Quality and global regulatory teams
- Support alignment with broader global regulatory strategies
What We’re Looking For
- 8+ years’ Regulatory Affairs experience within medical devices
- Strong experience with Class III devices (essential)
- Proven expertise in EU MDR and CE Marking (essential)
- Deep, hands-on experience with Technical Files / Design Dossiers
- Experience supporting products in development, not just lifecycle maintenance
- Strong track record engaging with Notified Bodies
- Combination product experience is desirable, but not essential
- A strategic mindset with the ability to influence across a complex organisation
Why This Role?
- Work on a new, innovative device at a pivotal stage of development
- Take on a highly visible, strategic position with real ownership and impact
- Shape the success of a programme that will directly improve patient outcomes
- Be part of an organisation where regulatory is viewed as a core strategic function
Location & Eligibility
- 100% on-site role based in West Oxford, UK
- Relocation support is available for the right candidate
For more information, please reach out to me at