Clinical Safety Lead

Medelic Ltd.; Greater London; On-site; GBP 70,000 - 120,000; Full time

Benefits offered by this job

Equity: Meaningful equity stake

Private health insurance

25 days holiday + bank holidays

£1,500 annual learning budget

Flexible working (hybrid or remote)

Enhanced parental leave

Job summary

Medelic is seeking a Clinical Safety Lead to own our clinical governance framework end-to-end, ensuring patient safety and regulatory compliance across all features, model updates, and product decisions. You will collaborate with engineering, product and clinical teams to embed safety into every development stage.

You will lead DCB0129 compliance, conduct clinical risk assessments for new features, design validation studies, and manage incident response.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Registered healthcare professional

Health IT experience

UK healthcare regulations

Analytical and documentation skills

Communication with technical and clín

Education

DCB0129 Clinical Safety Officer certification

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