Senior Device Risk Lead – Hybrid, Global Compliance

GlaxoSmithKline; Upper Providence (Delaware County); Hybrid; USD 120,000 - 180,000; Full time

Job summary

GSK is seeking a Senior Risk Management Engineer to establish, execute and improve risk management for medical devices and drug-device combinations across PDDS, in line with ISO 14971 and global regulations. You will own RMF, perform risk assessments, and drive risk controls throughout product lifecycles.

The role requires strong collaboration with engineering, quality, operations and regulatory teams, and will involve on-site or hybrid work at sites in the US and UK.

Qualifications

• Experience in risk management within regulated manufacturing or life sciences.
• Proficiency with ISO14971 risk methodologies such as FMEA/FTA.
• Strong collaboration with engineering, quality, operations and procurement teams.

Responsibilities

• Own the Risk Management File (RMF) for designated programs and lead risk assessments.
• Design and maintain risk frameworks, tools and documentation for consistent decision making.
• Lead cross-functional risk assessment workshops with multiple stakeholders to identify hazards and harms.
• Prepare risk rationales and evidence for regulatory inspections.

Skills

Risk management

ISO14971

FMEA/FTA

Cross-functional teamwork

Technical communication

Education

Degree in Engineering/Science/Risk Management

Job description

GSK is seeking a Senior Risk Management Engineer to establish, execute and improve risk management for medical devices and drug-device combinations across PDDS, in line with ISO 14971 and global regulations. You will own RMF, perform risk assessments, and drive risk controls throughout product lifecycles.

The role requires strong collaboration with engineering, quality, operations and regulatory teams, and will involve on-site or hybrid work at sites in the US and UK.