Clinical Assay Risk Management Specialist

Waters Corporation; Wilmslow; On-site; GBP 70,000 - 110,000; Full time

Benefits offered by this job

25 days holidays

Private medical insurance

Pension contributions

Life assurance

Income protection

Job summary

Waters Corporation is seeking a talented risk management professional to help shape the development of LC-MS clinical diagnostic assays. You will work with multidisciplinary teams to ensure risks are understood, controlled, and linked to design controls throughout product development.

The role requires experience with hazard analysis, DFMEA/PFMEA, and applying ISO 14971 in regulated medical device or IVD contexts, with a focus on analytical performance and clinical workflows.

Qualifications

• 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. Knowledge of ISO 14971 risk management principles in medical device/IVD development.

Responsibilities

• Shape development of LC-MS clinical diagnostic assays, ensuring risks are understood and controlled across the product lifecycle.
• Collaborate with scientists, engineers, clinicians, and regulatory specialists to deliver safe diagnostic solutions.
• Conduct risk assessments covering assay design, analytic performance, software functionality, and clinical workflows.
• Support hazard analysis and risk management activities to identify improvement opportunities.
• Maintain traceability between hazards, mitigations, requirements, verification results, and validation evidence.
• Prepare risk management documentation to support regulatory submissions and compliance with ISO 14971.

Skills

Risk management

DFMEA

Hazard analysis

IVD regulatory

Cross-functional

Technical writing

Education

Bachelor's in Chemistry/biochemistry/related

MSc/PhD desirable

Job description

Overview

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.

Qualifications

• 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.

In addition to salary, wework 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.

Company Description

Waters Corporation (NYSE:WAT)is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.

Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state,and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status,or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.