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About the Role

We are supporting a healthcare transformation consultancy headquartered in London. They are 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.

Responsibilities

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

Skills

SaMD
AI
Medical device classification
Risk assessment
Regulatory frameworks
MHRA
EU MDR
FDA

Location

London

Work Type

Contract
Hybrid

Experience Level

Consultant
Expert

Salary/Compensations

Negotiable
Outside IR35

About the Company

Healthcare transformation consultancy