Terumo Neuro in Aliso Viejo, CA seeks an experienced risk management professional to review risk impact assessments and design changes for product safety and efficacy, ensuring alignment with ISO 14971, 21 CFR 820, and EU MDR.
You will lead cross-functional risk analyses (PHA, FMEA), maintain risk management files, and drive continuous improvement of risk documentation while collaborating with Manufacturing, Quality, Regulatory Affairs, and R&D to support audits and lifecycle activities.
