Senior Device Risk Lead

GSK; East Hertfordshire; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

GSK is seeking a Senior Risk Management Engineer to establish, execute, and continuously improve risk management for medical devices and drug–device combinations across PDDS, in line with ISO 14971 and global regulations. The role involves owning RMFs, executing risk assessments, and ensuring risk controls are verified throughout product lifecycles.

The role requires strong collaboration with engineering, quality, operations and regulatory teams, and includes coaching teams on risk thinking

Qualifications

• Degree in Engineering, Science, Risk Management, or related discipline.
• Experience in risk management within regulated manufacturing or life sciences.
• Practical experience with ISO14971 risk methodologies such as FMEA or FTA.

Responsibilities

• Serve as PDDS risk owner for designated device and combination product programmes, owning the RMF and leading risk assessments.
• Design and maintain risk frameworks, tools and documentation to support consistent decision making.
• Run failure mode analysis, hazard assessments and root cause investigations with cross‑functional teams.
• Lead cross-functional risk assessment workshops with Human Factors, Device Engineering, Formulation, Primary Packaging, Clinical, Safety, Regulatory, Quality and Manufacturing stakeholders.
• Support regulatory and audit readiness by preparing risk rationales and evidence for inspections.
• Coach and uplift site and project teams in risk thinking, tools and best practice.

Skills

Risk management

FMEA

FTA

ISO 14971

Cross-functional collaboration

Regulatory knowledge

Communication

Education

Engineering degree

Science degree

Risk Management qualification

Job description

GSK is seeking a Senior Risk Management Engineer to establish, execute, and continuously improve risk management for medical devices and drug–device combinations across PDDS, in line with ISO 14971 and global regulations. The role involves owning RMFs, executing risk assessments, and ensuring risk controls are verified throughout product lifecycles.

The role requires strong collaboration with engineering, quality, operations and regulatory teams, and includes coaching teams on risk thinking