* Regulatory Affairs Manager, Class III Medical Device
* West Oxfordshire, UK – 5x a week on site
* Full-time, permanent role
* Up to £90,000 + Bonus
An industry‑leading medical device organisation is seeking an experienced Regulatory Affairs Manager to support major expansion and development initiatives at one of its flagship manufacturing sites. This includes playing a pivotal role in the regulatory strategy for a new Class III medical device, offering genuine scope to influence high‑impact, cutting‑edge healthcare innovations.
This role requires the right candidates to be based 100% on site in West Oxfordshire. The business can offer relocation support for candidates based 50 miles + away from the site location – But candidates must already be living in the UK and hold the full right to work in the UK with no restrictions now or in the future.
The Role
As Regulatory Affairs Manager, you will define and deliver UK/EU regulatory strategy across a diverse portfolio of products, including a significant new Class III device development project. You will oversee regulatory project management and act as a key partner to global Regulatory Affairs teams, R&D, Clinical Affairs, and wider cross‑functional groups.
Key Responsibilities
* Develop and maintain well‑defined regulatory strategies for new and existing products, including a high‑profile Class III device.
* Lead regulatory project management activities, coordinating with global RA teams and internal development functions.
* Maintain strong communication channels with Clinical Affairs, R&D, and global regulatory partners.
* Support inspections and external audits, including FDA and ISO assessors reviewing technical documentation.
* Provide leadership on Notified Body engagement and global product registration strategies.
* Ensure products meet all relevant regulatory, quality, and corporate requirements.
* Uphold Quality System effectiveness and compliance with site EHS policies.
* Communicate effectively with Notified Bodies, Competent Authorities and regulatory bodies.
About You
* Bachelor’s degree (or equivalent) in a scientific discipline such as Chemistry, Biology, or Life Sciences.
* Prior Class III medical device experience is essential and ideally combination product experience.
* Regulatory affairs experience within the medical device or healthcare manufacturing sector.
* Strong knowledge of ISO 13485, EMC, MDD 93/42/EEC, IVDD 98/79/EC, MDR 2017/745, IVDR 2017/756, and FDA QSR.
* Ability to interpret and apply complex regulatory requirements to product design and manufacturing.
* Skilled communicator, able to prepare clear documentation and influence internal and external stakeholders.
* Depth of regulatory experience enabling the creation of effective regulatory strategies and innovative approval pathways.
You’ll be working at the forefront of medical device innovation, contributing directly to the development and regulatory pathway of a new Class III product. This is a unique opportunity to shape regulatory strategy within a forward‑thinking organisation committed to improving patient outcomes globally.
For more information, please reach out to me at