Clinical Safety & AI Assurance Lead

Start:
Upon acquisition of our first healthcare client

Risk Line is building an AI assurance platform for healthcare.

Our focus is simple:

Help healthcare organisations and AI/health-tech vendors continuously understand, evidence and manage the clinical, regulatory and AI-governance risks of AI-enabled systems across UK and EU regulatory environments.

We are looking for an experienced Clinical Safety & AI Assurance Lead to work with us as we move from MVP into our first healthcare deployments.

This is not a traditional compliance or documentation role.

You will help us turn real clinical-safety expertise into a product that can continuously identify, test, evidence and monitor risks across the lifecycle of healthcare AI.

UK | Initial part-time / fractional | £50,000–£60,000 FTE equivalent (£450–£600/day depending on experience)

• Define and validate Risk Line's clinical-risk assessment and assurance model.
• Help translate clinical safety practice into structured, testable controls that can be represented within software.
• Review and challenge our approach to DCB
  0129/DCB
  0160, clinical-risk management, hazard identification, mitigations and evidence.
• Design realistic clinical-risk scenarios and test cases for AI-enabled healthcare systems.
• Test Risk Line against real-world AI use cases including clinical decision support, diagnostics, summarisation, documentation, patient-facing AI and other digital-health applications.
• Help us distinguish genuine clinical risk from low-value administrative/compliance activity.
• Work with AI vendors to understand the risks of their products before and after deployment.
• Work with healthcare organisations to understand the risks introduced when AI systems are deployed into real clinical workflows.
• Help define what should be monitored continuously rather than assessed only once.
• Review Risk Line outputs for clinical relevance, accuracy, proportionality and usability.
• Help develop evidence and reporting that a Clinical Safety Officer, healthcare organisation, AI vendor or auditor could actually use.
• Work closely with our engineering team to convert clinical requirements into product features and automated assurance tests.
• Participate in client discovery, product demonstrations and early customer implementations.

You should ideally be a UK-registered healthcare professional with substantial experience in clinical safety, digital health, health technology or patient-safety governance.

Particularly valuable experience includes:

• DCB
  0129 / DCB
  0160
• Clinical Risk Management
• Clinical Safety Officer experience
• NHS digital technology
• Digital health / Health Tech
• AI-enabled healthcare
• Medical devices / SaMD
• ISO 14971
• ISO 13485
• DTAC
• Clinical risk assessment and hazard management

Experience working on both the technology supplier/manufacturer and healthcare-provider/deployer sides would be particularly valuable.

You do not need to be a software engineer.

However, you must be comfortable working closely with engineers and challenging how software represents clinical risk.

Within the first 90 days, you should help us:

• Validate Risk Line's clinical-risk model against real healthcare use cases.
• Establish a practical clinical-risk taxonomy suitable for software implementation.
• Create a library of representative healthcare AI risk scenarios and test cases.
• Validate our approach to DCB
  0129/DCB
  0160 and related clinical-safety evidence.
• Test the product with at least one AI/Health Tech vendor and/or healthcare organisation.
• Identify gaps between conventional clinical-safety assurance and continuous AI assurance.
• Help turn those gaps into concrete Risk Line product capabilities.
• Establish a repeatable clinical-assurance methodology that can scale beyond a single…