Regulatory Affairs Manager

Cure Talent is working with an early-stage medical technology company developing AI-enabled software for clinical decision support. As the business prepares to expand its product portfolio and enter additional international markets, they are looking to appoint a Regulatory Affairs Manager.

This is a fully remote position within the UK, offering the opportunity to take ownership of regulatory activities within a small, technically focused team.

As the Regulatory Affairs Manager, you will work closely with software development, clinical and quality colleagues to develop regulatory strategies, prepare technical documentation and support regulatory submissions across the UK, EU and US.

Key Responsibilities

• Develop and implement regulatory strategies for AI-enabled Software as a Medical Device (SaMD).

• Lead preparation and maintenance of technical documentation under EU MDR and UK medical device regulations.

• Support FDA regulatory submissions, including 510(k) and De Novo pathways where appropriate.

• Provide regulatory input throughout software development, verification, validation and product change activities.

• Work closely with engineering teams to ensure alignment with IEC 62304, ISO 14971 and applicable regulatory requirements.

• Monitor evolving regulatory requirements relating to AI-enabled medical devices.

Experience and Skills Required

• Proven Regulatory Affairs experience within the medical device industry, particularly SaMD or AI-enabled medical devices.

• Strong working knowledge of EU MDR and medical device technical documentation.

• Experience developing regulatory strategies and supporting submissions.

• Understanding of IEC 62304, ISO 14971 and software lifecycle requirements.

• Experience working within a start-up or scale-up environment would be advantageous.

• Ability to operate independently and communicate effectively with technical and clinical stakeholders.

This is an opportunity to take ownership of regulatory activities within an innovative MedTech start-up, contributing directly to the development and commercialisation of new software-based medical technologies.

Interested?

Apply today or contact Cure Talent for a confidential discussion.