Senior Risk Management Engineer / Scientist
Core
Lead the establishment, maintenance, and remediation of Risk Management Files (RMFs) for medical devices and combination products across the full lifecycle, ensuring compliance with global regulations and standards.
Role type
Senior Risk Management Engineer / Scientist (Medical Devices)
Builds
Risk Management Files (RMFs), Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), Medical Hazard Lists
Domain
Healthcare / Medical Devices / Regulatory Compliance
Required skills
Risk Management process implementation, FMEA, FTA, Medical Hazard Analysis, Regulatory compliance (FDA 21 CFR 820, EUMDR), Change Control assessment, CAPA management, Stakeholder engagement, Design control
Preferred skills
New Product Introduction (NPI) experience, Lifecycle Management, Post-market surveillance, Quality Management System (QMS) knowledge
Technologies
ISO 14971:2019, ISO 13485, 21CFR 820, EUMDR 2017/745
Responsibilities
Lead Device Program Teams in developing RMF deliverables; Assess RMFs against on-market data; Collaborate with Quality, Clinical, and Pharmacovigilance teams; Lead assessment of Change Controls and Quality Incidents; Contribute to regulatory submissions and audits.
Seniority
Senior, hands-on IC