Clinical Risk Lead

Building an AI‑first organisation is central to Clinisys’ purpose and the impact we deliver. As a global provider of intelligent diagnostic informatics solutions, we build AI‑enabled, cloud‑based platforms to enhance diagnostic workflows across healthcare, life sciences, and public health. By applying intelligent technology thoughtfully and responsibly, we help laboratories and testing environments operate more effectively, generate meaningful insights at scale, and ultimately support healthier and safer communities. Operating across more than 30 countries, Clinisys expects all colleagues—regardless of role or function — to work confidently with AI‑enabled tools, apply digital and analytical thinking, and continuously adapt as technologies evolve, must drive an AI first sense of purpose and urgency.

Clinisys has built an unrivalled reputation for deploying complex diagnostic networks and academic centres – and is the only provider to repetitively deliver to all disciplines end-to-end – at scale. Fostering healthier communities. 

The Complaints & Clinical Risk Quality Analyst is responsible for the investigation, analysis, trending, and resolution of customer complaints, clinical safety issues, and product-related risks across the Clinisys product portfolio. The role supports complaint handling, post-market surveillance, and clinical risk management activities to ensure compliance with applicable regulatory requirements while driving improvements in patient safety, product quality, and risk management practices.

• 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.

• Bachelor's degree in Life Sciences, Healthcare, Nursing, Biomedical Engineering, Clinical Laboratory Science, Quality, Regulatory Affairs, Information Technology, 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 Software as a Medical Device (SaMD) products.

• Experience with electronic Quality Management Systems (eQMS), complaint management systems, risk management tools, and data analysis platforms.

• Experience using AI-enabled tools to support complaint trending, signal detection, and investigation activities.

• Experience with Laboratory Information Systems (LIS) or Laboratory Information Management Systems (LIMS).

• Knowledge of statistical analysis and trend monitoring methodologies.

• Experience supporting internal audits, external audits, customer assessments, or regulatory inspections.

• Experience across the full product lifecycle, including development, post-market surveillance, complaint handling, and risk management.
  

This role requires a working knowledge of Artificial Intelligence (AI) technologies and the ability to leverage them to improve processes and outcomes. A core understanding of AI concepts is required and must be able to demonstrate the use of AI tools in a professional setting.

Onboarding
As part of our onboarding process, all new employees will be required to attend / travel to the office on their first day of employment. This requirement is essential for onboarding activities, including the identity verification, completion of necessary documentation, receiving your IT equipment, introductions to key team members, and orientation to Clinisys policies and procedures.

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