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(Cancel)MHRA AI Regulatory Specialist – 5 day Contract across 8 weeks (Consultant II)
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Role Description
MHRA AI Regulatory Specialist – Contract
Contract: 5-day advisory engagement delivered over 4–8 weeks
Location: UK-based (Remote)
Engagement Type: Independent Contractor
Sector: Life Sciences / AI / Digital Health
Our consultancy is supporting several life sciences clients whose AI-powered solution is approaching regulatory readiness. We are seeking an experienced AI Regulatory Specialist with deep expertise in UK medical device regulation, Software as a Medical Device (SaMD), and MHRA engagement to provide targeted advisory support throughout the regulatory pathway.
This is a specialist consulting engagement focused on ensuring the client's AI solution has been designed, developed, evidenced, and documented in accordance with applicable UK regulatory requirements. Working as part of our client-facing team, you will provide expert guidance on regulatory strategy, submission readiness, clinical safety, and AI governance considerations.
The engagement comprises approximately 5 days of specialist consultancy effort, delivered flexibly across a 4–8 week period, aligned to key milestones within the client's Proof of Concept and regulatory preparation activities.
Key Responsibilities
Regulatory Assessment & Readiness
- Assess the client's AI solution and determine the appropriate regulatory classification under the UK Medical Devices Regulations 2002 (as amended).
- Evaluate whether the product qualifies as Software as a Medical Device (SaMD) and advise on the application of the IMDRF SaMD framework.
- Review the solution's design, development, validation, and governance approach against MHRA expectations for AI-enabled medical technologies.
- Identify regulatory gaps, risks, and remediation activities required before submission.
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AI Compliance & Governance
- Advise on regulatory expectations relating to AI model development, validation, monitoring, transparency, explainability, robustness, and bias mitigation.
- Support alignment with emerging MHRA AI as a Medical Device (AIaMD) guidance and Good Machine Learning Practice (GMLP) principles.
- Assess compliance considerations relating to UK GDPR, health data governance, and clinical data management.
- Provide guidance on DCB0129 and DCB0160 clinical safety requirements where applicable.
Submission Preparation
- Review and advise on Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs), and Post-Market Surveillance (PMS) documentation.
- Support the development of a regulatory roadmap covering pre-submission activities, approval requirements, and post-market obligations.
- Advise on conformity assessment routes and Approved Body considerations where relevant.
- Contribute to submission readiness activities and support responses to regulatory queries.
Stakeholder Advisory
- Act as the lead regulatory subject matter expert within the engagement team.
- Provide practical, business-focused guidance to client stakeholders across leadership, R&D, product, quality, and clinical functions.
- Clearly communicate regulatory requirements, timelines, risks, and dependencies.
- Produce concise written recommendations and progress updates throughout the engagement.
Essential Experience
- Proven experience advising on MHRA regulatory pathways for AI, digital health, software, or medical device products.
- Strong working knowledge of UK Medical Devices Regulations 2002 (as amended) and current MHRA guidance relating to Software as a Medical Device (SaMD).
- Hands-on experience supporting MHRA submissions, regulatory reviews, or approval processes.
- Experience applying the IMDRF SaMD risk framework.
- Demonstrable understanding of AI governance considerations within regulated healthcare or life sciences environments.
- Experience reviewing or preparing Technical Files, Design Dossiers, Clinical Evaluation Reports, and Post-Market Surveillance documentation.
- Knowledge of DCB0129 and DCB0160 clinical safety standards.
- Understanding of UK GDPR and data governance requirements relating to health and life sciences data.
- Strong stakeholder engagement and written communication skills.
- Experience operating as an independent consultant or specialist advisor within client-facing engagements.
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Desirable Experience
- Background in life sciences, biomedical science, bioengineering, clinical sciences, medical technology, or a related field.
- Experience supporting pharmaceutical, biotech, diagnostics, digital health, or MedTech organisations.
- Familiarity with ISO 13485 and IEC 62304 requirements.
- Knowledge of EU MDR, FDA AI/ML regulatory frameworks, or broader international AI medical device regulations.
- Awareness of NHS AI and Digital Regulations Service guidance and NICE Evidence Standards Framework.
- Professional regulatory qualifications such as RAC, TOPRA, or equivalent.
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Skills
- Life sciences
- Artificial intelligence
- Regulatory domain
- Biotechnology
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