Clinical Safety Lead

Posted 8 days 6 hours ago by Medelic

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
What We're Looking For
  • 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
Nice to Have
  • 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