Clinical Risk Lead – 12-Month Fixed-Term Contract

Jobtailor; Woking; On-site; GBP 50,000 - 75,000; Full time

Job summary

Jobtailor is seeking a Quality & Regulatory Assurance professional in the United Kingdom to manage complaint handling through the lifecycle, support post-market surveillance, and participate in clinical risk management. The role collaborates with Clinical Safety Officers, Product Management, R&D, and Customer Support to address complex safety and product quality issues.

The ideal candidate has 4–7 years of experience in regulated industries, with knowledge of ISO 14971, UK MDR, and EU MDR/IVDR,

Qualifications

• 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
• Working knowledge of Artificial Intelligence technologies and ability to leverage AI tools in a professional setting
• Experience with electronic Quality Management Systems (eQMS), complaint management systems, risk management tools, and data analysis platforms
• Experience using AI-enabled tools for 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

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 through collection, analysis, and interpretation of complaint, service, customer feedback, and product performance data
• Participate in clinical risk management, including hazard identification, risk assessment, risk evaluation, verification of risk-control effectiveness, and hazard-log maintenance
• Collaborate with Clinical Safety Officers, Product Management, R&D, and Customer Support teams on complex clinical safety and product quality issues
• Use AI-enabled tools and data analytics to improve complaint trending, signal detection, root cause analysis, and recurring-issue identification
• Support compliance with applicable regulatory requirements and improvements in patient safety, product quality, and risk management

Skills

Collaboration

Communication

Problem-Solving

Education

Bachelor's degree in Life Sciences

Tools

eQMS

Complaint Management

Risk Management Tools

Data Analytics

LIS/LIMS

AI Tools

Job description

• 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 through collection, analysis, and interpretation of complaint, service, customer feedback, and product performance data
• Participate in clinical risk management, including hazard identification, risk assessment, risk evaluation, verification of risk-control effectiveness, and hazard-log maintenance
• Collaborate with Clinical Safety Officers, Product Management, R&D, and Customer Support teams on complex clinical safety and product quality issues
• Use AI-enabled tools and data analytics to improve complaint trending, signal detection, root cause analysis, and recurring-issue identification
• Support compliance with applicable regulatory requirements and improvements in patient safety, product quality, and risk management

Requirements

• 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
• Working knowledge of Artificial Intelligence technologies and ability to leverage AI tools in a professional setting
• Experience with electronic Quality Management Systems (eQMS), complaint management systems, risk management tools, and data analysis platforms
• Experience using AI-enabled tools for 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

Core Competencies

Demonstrates expertise in complaint handling, clinical risk management, and regulatory compliance within the medical device industry. Proficient in utilizing AI-enabled tools and data analytics for effective complaint trending and root cause analysis.

Highest-signal resume keywords

• Complaint Handling
• Clinical Risk Management
• Regulatory Compliance
• Root Cause Analysis
• Post-Market Surveillance

Hard Skills

• Quality Management
• Risk Management Principles
• CAPA Processes
• Statistical Analysis
• ISO 14971
• DCB0129
• DCB0160
• UK MDR
• EU MDR/IVDR
• FDA 21 CFR Part 820

Soft Skills

• Collaboration
• Communication
• Problem-Solving

Industry Keywords

• Medical Devices
• Diagnostics
• Healthcare Software
• Software as a Medical Device (SaMD)
• Regulated Industry

Tools & Technologies

• Electronic Quality Management Systems (eQMS)
• Complaint Management Systems
• Risk Management Tools
• Data Analysis Platforms
• Laboratory Information Systems (LIS)
• Laboratory Information Management Systems (LIMS)
• AI-Enabled Tools