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Clinical Safety Lead
Posted 16 days 7 hours ago by Medelic Ltd.
Permanent
Full Time
Other
London, United Kingdom
Job Description
We're looking for a Clinical Safety Lead to own our clinical governance framework end-to-end. You'll ensure that every feature, every model update, and every product decision meets the highest standards of patient safety and regulatory compliance.
This is a critical role at Medelic. We're building AI that helps with clinical decision-making, and we take that responsibility seriously. You'll work across the entire company - with engineering, product, and clinical teams, to embed safety into everything we do.
What You'll Do- Own and evolve our clinical safety management system
- Lead DCB0129 compliance and maintain our Clinical Safety Case
- Conduct clinical risk assessments for new features and changes
- Design and oversee clinical validation studies
- Work with engineering to build safety monitoring and alerting systems
- Chair our Clinical Safety Group and manage incident response
- Liaise with regulators and maintain our MHRA registration
- Build relationships with clinical advisors and external safety experts
- Registered healthcare professional (GMC, NMC, or equivalent)
- DCB0129 Clinical Safety Officer certification
- 3+ years of experience in clinical safety or clinical governance
- Experience with health IT systems and digital health products
- Strong understanding of UK healthcare regulations (MHRA, CQC)
- Excellent analytical and documentation skills
- Ability to communicate effectively with technical and clinical teams
- Experience with AI/ML-based medical devices
- Background in primary care or general practice
- Familiarity with ISO 13485 or IEC 62304
- Experience with EU MDR compliance
- Equity: Meaningful equity stake in a growing company
- Private health insurance
- 25 days holiday + bank holidays
- £1,500 annual learning budget
- Flexible working (hybrid or remote)
- Enhanced parental leave
Medelic Ltd.
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