AI-Powered Clinical Risk & Quality Lead

Clinisys; Woking; On-site; GBP 55,000 - 85,000; Full time

Job summary

Clinisys, a global provider of diagnostic informatics solutions, seeks a Complaints & Clinical Risk Quality Analyst to investigate complaints and medical device risks across the portfolio. You will support post‑market surveillance, CAPA, and risk management to enhance patient safety and regulatory compliance.

In close collaboration with Clinical Safety Officers, Product Management, R&D, and Customer Support, you will analyse data, perform RCA, and drive improvements using AI-enabled tools and

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, or a related discipline.
• 4-7 years' experience in Quality, Clinical Safety, Complaint Handling, Post‑Market Surveillance, Regulatory Affairs, or Risk Management within a regulated industry.
• Minimum 5 years' experience working with DCB0129 (preferred) and/or DCB0160.
• Experience investigating customer complaints, incidents, adverse events, and product quality issues.
• Experience applying risk management principles in accordance with ISO 14971 or equivalent risk management frameworks.
• Experience with CAPA processes, root cause analysis methodologies, and effectiveness verification activities.
• Working knowledge of UK MDR, EU MDR/IVDR, FDA 21 CFR Part 820/QMSR, and ISO 13485.
• Experience supporting medical devices, diagnostics, healthcare software, laboratory systems, or SaMD products.

Responsibilities

• Manage and support complaint handling activities throughout the complaint lifecycle, including intake, triage, investigation, root cause analysis, corrective actions, and closure.
• Support post‑market surveillance activities through the collection, analysis, and interpretation of complaint, service, customer feedback, and product performance data.
• Participate in clinical risk management activities, including hazard identification, risk assessment, risk evaluation, verification of risk control effectiveness, and maintenance of hazard logs.
• Collaborate with Clinical Safety Officers, Product Management, R&D, and Customer Support teams to investigate complex clinical safety and product quality issues.
• Utilize AI‑enabled tools and data analytics to improve complaint trending, signal detection, root cause analysis, and identification of recurring issues.

Skills

Quality Management

Post-Market Surveillance

Risk Management

CAPA Processes

Root Cause Analysis

Data Analytics

AI Tools

Regulatory Affairs

ISO 13485 knowledge

Education

Bachelor's degree in Life Sciences, Healthcare, Nursing, Biomedical Engineering, Clinical Laboratory Science, Quality, Regulatory Affairs, Information Technology, or a related discipline

Tools

eQMS

LIS/LIMS

Quality management software

Audit management tools

Job description

Clinisys, a global provider of diagnostic informatics solutions, seeks a Complaints & Clinical Risk Quality Analyst to investigate complaints and medical device risks across the portfolio. You will support post‑market surveillance, CAPA, and risk management to enhance patient safety and regulatory compliance.

In close collaboration with Clinical Safety Officers, Product Management, R&D, and Customer Support, you will analyse data, perform RCA, and drive improvements using AI-enabled tools and