Sr Specialist, Product Safety Risk Management
Core
Owns and maintains ISO 14971-compliant risk management processes for regulated and non-regulated medical imaging software devices across the full product lifecycle.
Role type
Senior Specialist, Product Safety Risk Management (Medical Device Software)
Builds
Safety risk management files, hazard analyses, FMEAs, fault tree analyses, and benefit-risk analyses for SaMD.
Domain
Healthcare technology / Medical Devices / Software as a Medical Device (SaMD)
Required skills
ISO 14971 application, hazard identification, risk analysis, risk evaluation, risk control, regulatory interpretation (21 CFR 820, MDR, Canada MDR), CAPA management, post-market surveillance, cross-functional collaboration, systematic problem-solving.
Preferred skills
Agile development environments, cloud-based solutions, advanced training in medical device safety risk management.
Technologies
Jira, Xray Test Management, Microsoft 365
Responsibilities
Own and maintain safety risk management process in conformance with ISO14971; Ensure effective execution of safety risk management activities including hazard identification, risk analysis, risk evaluation, risk control, and residual risk assessment; Collaborate with cross-functional development teams to integrate safety risk management into design controls; Develop, maintain, and approve risk management files and associated documentation; Partners with clinical, human factors/usability, and cybersecurity teams to ensure comprehensive identification and control of safety risks; Evaluates the effectiveness of risk control measures and ensures traceability and linkage to verification, validation, and usability evidence; Supports post-market safety activities including Health Hazard Evaluations, complaint investigations, field safety corrective actions, and post-market surveillance trending; Identifies emerging safety risks and proactively drives corrective and preventive actions (CAPA); Develops and tracks safety and risk-related quality metrics; Contributes safety risk management content to regulatory submissions and change assessments; Participates in and supports internal and external audits and inspections as a safety risk management subject matter expert.
Seniority
Senior, hands-on IC
