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MHRA AI Regulatory Specialist – Remote Contract
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MHRA AI Regulatory Specialist – Contract
Contract: 5-day advisory engagement (4–8 weeks, outside IR35)
Location: UK-based (remote)
Engagement Type: Independent Contractor
Sector: Life Sciences / AI / Digital Health
Our consultancy is supporting life sciences clients whose AI-powered solutions are approaching regulatory readiness. We are seeking an experienced AI Regulatory Specialist with expertise in:
- UK medical device regulation
- Software as a Medical Device (SaMD)
- MHRA engagement
This is a specialist advisory engagement focused on ensuring alignment with applicable UK regulatory requirements. Your role will involve providing expert guidance on regulatory strategy, submission readiness, clinical safety, and AI governance.
Engagement Overview
4–8 weeks of flexible delivery, spanning key milestones in Proof of Concept (PoC) and regulatory preparation.
Key Responsibilities
Regulatory Assessment & Readiness
- Assess the AI solution for UK Medical Devices Regulations 2002 compliance and appropriate classification.
- Determine whether the product qualifies as SaMD and apply the IMDRF SaMD framework.
- Review design, development, validation, and governance approaches against MHRA expectations for AI-enabled medical technologies.
- Identify regulatory gaps, risks, and remediation activities for submission readiness.
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AI Compliance & Governance
- Advise on AI model development, validation, monitoring, transparency, explainability, robustness, and bias mitigation.
- Align the solution with MHRA AI as a Medical Device (AIaMD) guidance and Good Machine Learning Practice (GMLP).
- Assess UK GDPR, health data governance, and clinical data management compliance.
- Provide DCB0129 and DCB0160 clinical safety guidance where applicable.
Submission Preparation
- Review and advise on Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs), and Post-Market Surveillance (PMS) documentation.
- Develop a regulatory roadmap covering pre-submission, approval, and post-market obligations.
- Guide conformity assessment routes and Approved Body considerations.
- Support submission readiness activities and regulatory query responses.
Stakeholder Advisory
- Act as the lead regulatory subject matter expert in the engagement team.
- Provide practical, business-focused guidance to stakeholders across leadership, R&D, product, quality, and clinical functions.
- Clarify regulatory timelines, risks, and dependencies.
- Produce concise written recommendations and progress updates.
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Essential Experience
- Proven experience advising on UK MHRA regulatory pathways for AI/medical device products.
- Strong knowledge of UK Medical Devices Regulations 2002 (as amended) and related MHRA SaMD guidance.
- Hands-on experience supporting MHRA submissions or regulatory reviews.
- IMDRF SaMD risk framework application experience.
- Understanding of AI governance in regulated healthcare.
- Experience reviewing Technical Files, Design Dossiers, CERs, and PMS documentation.
- Knowledge of DCB0129/160 clinical safety requirements.
- Understanding of UK GDPR and health data governance.
- Strong stakeholder engagement and written communication.
- Relevant independent consulting/contracting experience.
Desirable Experience
- Life sciences/biomedical/bioengineering background.
- Support for pharma, biotech, diagnostics, digital health, or MedTech organisations.
- Familiarity with ISO 13485 and IEC 62304.
- Knowledge of EU MDR, FDA, or international AI medical device regulations.
- Awareness of NHS AI Digital Guidance and NICE Evidence Standards.
- Professional qualifications: RAC, TOPRA, or equivalent.
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