IVD Regulatory Lead – Cambridge MedTech

Cure Talent Ltd; Cambourne; On-site; GBP 60,000 - 80,000; Full time

Job summary

Cure Talent Ltd in Cambridgeshire is partnering with a diagnostics company to recruit a Regulatory Affairs Manager. You will own day-to-day regulatory activities, maintain technical documentation, and ensure compliance for UKCA and CE marked products, while supporting the IVD development programme.

The role requires hands-on experience in Medical Device or IVD regulatory affairs, strong cross-functional collaboration, and the ability to work independently in a small team.

Qualifications

• Proven Regulatory Affairs experience within the Medical Device or IVD industry, with an IVD or diagnostics background strongly preferred.
• Hands-on experience developing, maintaining and reviewing technical documentation.
• Good working knowledge of UK and European Medical Device regulations (MDR/IVDR).
• Experience supporting regulatory activities across product development, risk management, performance evaluation or post‑market activities.

Responsibilities

• Maintain, review and develop technical documentation for existing and future Medical Device and IVD products.
• Support UKCA and CE marking activities, including product changes, lifecycle management and regulatory documentation updates.
• Contribute to the development and implementation of regulatory strategies for new diagnostic products and the wider IVD programme.
• Support regulatory activities across risk management, performance evaluation and post-market surveillance.
• Work closely with Scientific, Data, R&D and Quality teams to ensure regulatory requirements are understood and incorporated throughout product development.

Skills

Regulatory Affairs

UKCA/CE marking

Technical docs

MDR/IVDR

Cross-functional

Job description

Cure Talent Ltd in Cambridgeshire is partnering with a diagnostics company to recruit a Regulatory Affairs Manager. You will own day-to-day regulatory activities, maintain technical documentation, and ensure compliance for UKCA and CE marked products, while supporting the IVD development programme.

The role requires hands-on experience in Medical Device or IVD regulatory affairs, strong cross-functional collaboration, and the ability to work independently in a small team.