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AI Regulatory Specialist - MHRA Consultant II - UST
Software Engineer
Provide expert advisory support on UK medical device and MHRA regulations for AI‑driven SaMD solutions, guiding clients through regulatory strategy, documentation, and compliance to achieve market readiness.
About the role
Key Responsibilities
- Advise life‑science clients on UK Medical Device Regulation (MDR) and MHRA requirements specific to AI‑enabled Software as a Medical Device.
- Develop and review regulatory strategies, risk management files, and technical documentation to ensure compliance throughout the product lifecycle.
- Conduct clinical evaluation planning and support evidence generation for AI algorithms, including performance validation and post‑market surveillance considerations.
- Liaise with MHRA officials, prepare submission packages, and respond to queries during the approval process.
- Provide guidance on data governance, cybersecurity, and ethical considerations for AI in digital health applications.
Requirements
- Minimum 5 years of experience in regulatory affairs for medical devices, with a focus on AI‑driven SaMD.
- Deep knowledge of UK MDR, MHRA processes, and international standards (ISO 13485, IEC 62304, IEC 82304).
- Proven track record of preparing successful regulatory submissions and interacting with MHRA.
- Strong analytical skills and ability to translate technical AI concepts into regulatory documentation.
- Excellent communication skills and ability to work independently in a remote consulting environment.