Job Title: Regulatory Affairs Manager – Combination Product
Location: West Oxford, UK – 100% on site (Relocation support can be offered)
Job Type: Full-time, Permanent
Salary: £75,000 – £90,000 + Bonus + LTI’s
Cpl Life Sciences is collaborating with one of the world’s leading medical device manufacturers, who are looking for an experienced Regulatory Affairs Manager to support the development and approval of a novel combination product/device.
This is a hands-on, specialist role focused exclusively on a single, innovative product programme, offering the opportunity to work at the forefront of cutting-edge technology. This is a non-linear management position, ideal for a technically strong regulatory professional who thrives on ownership, detail, and end-to-end product involvement.
(Please note that this role is 100% based on site and you MUST be happy to commit to this. Relocation support is offered to candidates living 50 miles + away from the site, but you MUST hold the full right to work in the UK.)
Key Responsibilities:
- The role requires strong expertise in CE Marking, MDR, experience engaging with Competent Authorities and Notified Bodies, and a solid background in CTD dossier authoring.
- Lead regulatory activities for a novel combination product/device, supporting development through to approval and lifecycle
- Own and execute regulatory strategy for a single, high-priority product programme
- Act as the regulatory SME for combination product classification and pathway definition
- Support and contribute to the authoring and maintenance of CTD dossiers (Modules 1–5)
- Ensure alignment between device technical documentation and medicinal product submissions
- Work directly with Competent Authorities, Notified Bodies, MHRA, EMA, and other global regulators
- Prepare briefing documents, support meetings, and manage responses to regulatory queries
- Partner closely with R&D, Quality, Clinical, and Manufacturing teams
- Support integration of device and pharmaceutical regulatory requirements within the product development lifecycle
Experience Required:
- Degree in Life Sciences, Pharmacy, Engineering, or related discipline – Advanced degree preferred
- 5+ years in Regulatory Affairs, ideally within medical devices and combination products
- Hands-on experience leading a combination product to market in the UK and Europe.
- Experience working with Competent Authorities and/or Notified Bodies
- Familiarity with design control and risk management standards
- Strong communication and cross-functional collaboration skills
- Ability to operate in a focused, delivery-driven environment with high ownership
- Effective communicator with confidence working with regulatory authorities
Why join the business:
- Attractive salary, including a 15% bonus, LTIs (Up to $12,000), private healthcare, pension, life assurance, dental care + other benefits
- Full manufacturing + R&D labs + Clean rooms + Corporate office on site
- Regular events on site, including Pilates and yoga
- On-site canteen and restaurant
- Wellness room
For more information, please contact lucy.kirkaldy@cpl.com
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