Clinical Assay Risk Management Specialist at Waters Corporation in UK-Cheshire-Wilmslow

Job description

• Join Waters' Clinical Development organisation and help shape the future of clinical diagnostics by ensuring the safety, effectiveness, and reliability of innovative assays that support critical patient care decisions.
• Working as part of a highly collaborative, multidisciplinary team of assay scientists, systems engineers, software developers, quality professionals and regulatory specialists, you will play a pivotal role in bringing cutting-edge diagnostic solutions from concept to global deployment. At Waters, your work will directly contribute to improving healthcare outcomes worldwide, enabling clinicians and laboratories to deliver trusted results that positively impact patients' lives every day.

Responsibilities

• Help shape the development of innovative LC-MS clinical diagnostic assays by ensuring risks are understood, managed, and effectively controlled throughout the product lifecycle.
• Work collaboratively with scientists, engineers, clinicians, and regulatory specialists to support the delivery of safe and effective diagnostic solutions.
• Conduct and facilitate risk assessments covering assay design, analytical performance, software functionality, and clinical workflows.
• Support hazard analysis, DFMEA, and other risk management activities to identify opportunities for risk reduction and product improvement.
• Partner with cross-functional teams to define, implement, and verify effective risk control measures.
• Ensure risk management outputs are reflected in product requirements, verification activities, and design controls.
• Maintain traceability between hazards, mitigations, requirements, verification results, and validation evidence.
• Evaluate user workflows and operational processes to identify potential use-related risks and improve the overall user experience.
• Prepare and maintain risk management documentation to support regulatory submissions and compliance with ISO 14971 and other applicable standards.
• Contribute to a culture of quality, learning, and continuous improvement by sharing knowledge and supporting colleagues in applying best-practice risk management techniques.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Clinical Science, Biomedical Science, Engineering or related scientific discipline. Advanced degree (MSc or PhD) desirable.
• Experience developing in-vitro diagnostic assays, clinical laboratory tests or regulated analytical products. Experience applying ISO 14971 risk management principles within medical device or IVD development. Knowledge of IVD regulatory requirements including IVDR and FDA expectations.
• Understanding of assay development processes including reagent development, calibration strategies, quality controls and analytical performance evaluation. Understanding of assay verification and validation methodologies.
• Experience facilitating risk analyses such as Hazard Analysis, DFMEA, PFMEA and Fault Tree Analysis.
• Experience working within a multidisciplinary product development environment.
• Well-developed analytical and problem-solving skills, with the ability to understand complex clinical workflows and assay processes.
• Effective facilitation skills for risk reviews and cross-functional workshops.
• Excellent technical writing and documentation skills, with attention to detail and the ability to maintain risk and traceability information accurately and effectively.
• Ability to explore assumptions thoughtfully and contribute to evidence-based decision-making. Excellent verbal and written communication skills.
• Ability to work collaboratively across multidisciplinary and geographically distributed teams.
• Commitment to continuous learning and the ability to apply evolving regulatory and industry best practices.
• Some international travel may be required.

Skills

Required

• Analytical and problem-solving skills
• Facilitation skills
• Verbal and written communication skills
• Commitment to continuous learning
• ISO 14971
• IVDR
• FDA expectations
• Hazard Analysis
• DFMEA
• PFMEA
• Fault Tree Analysis
• Assay development

Benefits

• In addition to salary, we work flexibly and provide 25 days holidays, excellent family friendly benefits such as attractive employer pension contribution, life assurance, income protection and private medical. With Waters, there are plenty of opportunities for you to grow, develop and contribute.