Senior Risk Management Engineer

GSK; Collegeville (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

GSK in Collegeville, PA is seeking a Device Risk Management Lead to establish and continually improve risk management for medical devices and drug-device combinations, across PDDS, in accordance with ISO 14971 and global regulations. The role provides subject-matter expertise in device risk management and ensures that risk controls are identified and implemented.

The position requires ownership of key risk files and processes, guiding risk assessment activities, and collaboration across

Qualifications

• Role focuses on establishing, executing and improving risk management for medical devices per ISO 14971 and global regulations.

Responsibilities

• Own key risk files and processes; ensure risk controls are identified and implemented.

Job description

Closing Date: 25th September 2026 (COB)

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

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Our approach to R&D

Position Summary

The Device Risk Management Lead is accountable for establishing, executing, and continuously improving risk management for medical devices and drug-device combination products across PDDS, in accordance with ISO 14971 and applicable global regulations (e.g. EU MDR 2017/745, FDA 21 CFR 820). The role provides subject‑matter expertise in device risk management, owns key risk files and processes, and ensures that risk controls are appropriately identified, implemented