AI-Driven Clinical Risk & Quality Lead

Clinisys; Horsell; On-site; GBP 70,000 - 110,000; Full time

Job summary

Clinisys is seeking a Complaints & Clinical Risk Quality Analyst to investigate, analyze, trend and resolve customer complaints, clinical safety issues, and product risks across our diagnostic informatics portfolio. You will support complaint handling, post-market surveillance and regulatory compliance to improve patient safety and product quality.

You will work with Clinical Safety Officers, Product Management, R&D and Customer Support to investigate complex safety and quality issues, using

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 4–7 years' experience in Quality, Clinical Safety or Regulatory affairs within a regulated industry.
• Experience with DCB0129 and/or DCB0160 preferred.
• Experience investigating complaints, incidents and product quality issues.
• Knowledge of risk management per ISO 14971 or similar.
• Experience with CAPA processes and root cause analysis.
• Familiarity with UK MDR, EU MDR/IVDR, FDA QMSR, ISO 13485.
• Experience with SaMD, diagnostics or medical devices.

Responsibilities

• Manage complaint handling across the lifecycle (intake, triage, investigation, corrective actions, closure).
• Support post-market surveillance and data analysis for trends and signals.
• Participate in clinical risk management and hazard log maintenance.
• Collaborate with safety officers, PM, R&D and support teams to investigate complex issues.
• Use AI-enabled tools to improve trending, signal detection and RCA.

Skills

Quality management

Risk management

Complaint handling

Post-market surveillance

CAPA

Root cause analysis

Data analytics

AI tools

Regulatory affairs

ISO 13485

Education

Bachelor's degree in Life Sciences

Tools

eQMS

CAPA software

LIS/LIMS

Job description

Clinisys is seeking a Complaints & Clinical Risk Quality Analyst to investigate, analyze, trend and resolve customer complaints, clinical safety issues, and product risks across our diagnostic informatics portfolio. You will support complaint handling, post-market surveillance and regulatory compliance to improve patient safety and product quality.

You will work with Clinical Safety Officers, Product Management, R&D and Customer Support to investigate complex safety and quality issues, using