Clinical Diagnostics Risk Manager - Assay Quality

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

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.