Regulatory Affairs Manager

Cure Talent are delighted to be partnered with an established Medical Device company based in Oxfordshire. As they continue to develop and support their portfolio of complex implantable devices across international markets, we have an exciting opportunity for a Regulatory Affairs Manager to join the business and lead their Regulatory Affairs function.

As the new Regulatory Affairs Manager, you will take ownership of the day-to-day Regulatory Affairs activities while leading a small, established team. This is a hands‑on position, combining technical Regulatory work with team leadership, supporting ongoing MDR compliance, international registrations, product changes and regulatory submissions across Europe, the US and wider global markets.

This is a hybrid role with the expectation of being on site around 50% of your working week.

To be successful as the Regulatory Affairs Manager, you will be an experienced Medical Device Regulatory professional with strong hands‑on experience across technical documentation, submissions and product lifecycle activities. You do not need to be an established Manager, but you will need the experience and confidence to guide others, work across multidisciplinary teams and take the lead when regulatory issues become more complex or time‑critical.

Key Responsibilities

• Lead the day-to-day Regulatory Affairs function and support the development of a small team.
• Maintain and develop Technical Documentation for Class II and Class III Medical Devices in accordance with MDR requirements.
• Manage regulatory submissions, product registrations and change notifications across European and international markets.
• Support upcoming FDA activities, including a planned PMA submission, working alongside internal teams and external regulatory specialists.
• Oversee international registrations, including ongoing activities across markets such as China and South Korea.
• Assess the regulatory impact of design, manufacturing and supplier changes and ensure submissions are completed within required timelines.
• Manage relationships with Notified Bodies and regulatory authorities, ensuring regulatory activities and submissions remain on track.
• Work closely with Quality, R&D, Engineering, Operations and Commercial teams across pre‑market and post‑market activities.
• Support audits, vigilance, post‑market activities and regulatory responses where required.

Experience and Skills Required

• Proven Regulatory Affairs experience within the Medical Device industry
• Experience working with Class IIb or Class III Medical Devices, with implantable device experience particularly advantageous.
• Strong experience developing, maintaining and reviewing Technical Documentation.
• Practical experience with regulatory submissions, product registrations and change control activities.
• Good working knowledge of EU MDR and the regulatory requirements associated with higher‑risk Medical Devices.
• Experience working cross‑functionally and communicating regulatory requirements clearly to technical and non‑technical stakeholders.
• Previous people management experience is advantageous but not essential. Experience mentoring, coaching or providing technical leadership would also be considered.
• FDA submission experience would be advantageous, with PMA or IDE experience particularly valuable but not essential.
• International regulatory experience across markets outside Europe would also be beneficial.

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