Senior Risk Management Engineer / Scientist
Core
Establish, maintain, and remediate risk management files for medical devices and combination products throughout the product lifecycle, ensuring compliance with global regulations and standards.
Role type
Senior Risk Management Engineer / Scientist
Builds
Risk Management Files (RMFs), Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), Medical Hazard Lists, and regulatory submissions
Domain
Healthcare / Medical Devices / Drug-device combination products
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk Management process implementation, FMEA, FTA, Medical Hazard Analysis, regulatory compliance (FDA 21 CFR 820.30, EUMDR 2017/745, ISO 14971:2019), Change Control assessment, CAPA management, post-market surveillance, cross-functional collaboration
Preferred skills
New Product Introduction (NPI) / Lifecycle Management, Design Control, Quality Management System (QMS) application
Technologies
ISO 13485, ISO 14971:2019, FDA 21 CFR 820, EUMDR 2017/745
Responsibilities
Lead Device Program Teams in developing RMF deliverables; Assess RMFs against on-market data; Contribute to regulatory submissions and audits; Lead assessment of Change Controls, Complaint Investigations, and CAPAs; Collaborate with Quality, Clinical, and Pharmacovigilance teams; Drive process improvements in the Risk Management function
Seniority
Senior, hands-on IC