Cpl Life Sciences
Regulatory Affairs Manager - Combination Product
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Regulatory Affairs Manager - Combination Product
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
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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
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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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