Cure Talent and Medical Device Company Partnership

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.

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.