Job Description

Role: Regulatory Specialist (Medical Devices) - Contract role

Seniority: Consultant - Expert

Day rate: Negotiable and outside IR35

Project duration: 3 months (potential to extend), starting in June

Location: 2 days on-site in London, 3 days remote

We’re supporting a healthcare transformation consultancy, headquartered in London. They're seeking regulatory specialists with experience across life sciences and medical devices, ideally with exposure to SaMD (Software as a Medical Device) and AI. The role will support the assessment of medical device products from a regulatory, risk and classification perspective, helping clients navigate relevant requirements across key markets.

We’ve a preference for you to apply directly via the Project Blackbook website as the consultancy will eventually view your profile in our platform. If you are already in the community, feel free to quickly apply here or reach out to your Blackbook contact, but no need to re-apply directly.

Tasks

• Assess medical device and SaMD / AI products from a regulatory, risk and classification perspective
• Support the interpretation of relevant regulatory requirements across markets such as the UK, EU and US
• Provide practical guidance to project teams on regulatory considerations, documentation and compliance pathways

Requirements

• An independent consultant
• Experience in regulatory affairs within life sciences, medical devices, SaMD or digital health
• Understanding of medical device classification, risk assessment and regulatory frameworks, ideally including MHRA, EMA / EU MDR and FDA
• Ability to work with both technical and non-technical stakeholders, translating regulatory requirements into clear, practical advice