Sr Specialist, Product Safety Risk Management

The Senior Specialist, Product Safety Risk Management is responsible for supporting the safety of regulated and non-regulated medical imaging software devices through ownership and application of ISO 14971-compliant risk management processes. This role provides subject matter expertise in product safety risk management across the full product lifecycle, from concept and design through post-market surveillance. The Sr Specialist Product Safety Risk Management works closely with cross-functional stakeholders, including engineering, clinical, cybersecurity, human factors, and regulatory affairs, to proactively identify, evaluate, control, and monitor safety-related risks and continuously improve safety practices.

Responsibilities

Owns and maintains the safety risk management process in conformance with applicable regulations, standards, and guidance, including ISO14971, ensuring consistent implementation across the product lifecycle; Ensures effective execution of safety risk management activities throughout the product lifecycle, including hazard identification, risk analysis, risk evaluation, risk control, and residual risk assessment; Collaborates with cross-functional development teams to integrate safety risk management into design controls, architecture decisions, and development processes; Provides expert guidance on the interpretation and application of safety-related regulations, standards, and internal Quality Management System (QMS) procedures; Develops, maintains, and approves risk management files and associated documentation (e.g., hazard analyses, FMEAs, fault tree analyses, benefit-risk analyses); Partners with clinical, human factors/usability, and cybersecurity teams to ensure comprehensive identification and control of safety risks, including use-related and security-related hazards; 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 (HHEs), complaint investigations, field safety corrective actions, and post-market surveillance trending; Identifies emerging safety risks and proactively drives corrective and preventive actions (CAPA) in collaboration with cross-functional teams; Develops and tracks safety and risk-related quality metrics to support management review and contributes to continuous improvement; Contributes safety risk management content to regulatory submissions and change assessments, ensuring alignment with applicable regulatory expectations; Applies systematic problem-solving methodologies to assess safety issues, prioritize actions, and clearly communicate risk-based decisions; Promotes a culture of patient safety, risk awareness, collaboration and continuous improvement across the organization; Participates in and supports internal and external audits and inspections as a safety risk management subject matter expert, providing objective evidence and regulatory justification as required

Requirements

Minimum of 5 years of experience in safety risk management within healthcare technology, medical devices, or other regulated industries, preferably involving Software as a Medical Device (SaMD); Demonstrated practical experience applying ISO14971 to software-based medical devices across pre-market and post-market phases, including post-market feedback and risk management file updates; Strong understanding of design controls and their integration with safety risk management activities; Excellent analytical, problem-solving, and risk-based decision-making skills; Proven ability to collaborate effectively across multidisciplinary teams and influence without authority; Strong organizational and project management skills, with the ability to manage multiple priorities while maintaining attention to detail; Excellent written and verbal communication skills, including the ability to clearly document and justify risk-related decisions; Ability to work independently with minimal supervision in a collaborative team environment; In-depth knowledge of ISO 14971 and its application to medical device software; Working knowledge of related standards, including ISO 13485, IEC 62304, and IEC 62366-1; Knowledge of applicable regulatory frameworks, including 21 CFR Part 820 Quality System Regulation, Canada Medical Devices Regulations (SOR/98-282), and EU Medical Device Regulation (EU) 2017/745; Familiarity with software development lifecycles, including agile methods, and technology applications such as Jira, Xray Test Management, and Microsoft 365; Bachelor's degree in engineering, computer science, life sciences, or another technical or scientific discipline, or equivalent relevant experience

Nice to have

Advanced training or certification in medical device safety risk management; Experience with agile development environments and cloud-based solutions

Benefits

Remote first / work from home culture; Flexible vacation; Paid leave benefits; Health, dental, and vision insurance; 401k retirement savings plan; Infertility benefits; Tuition reimbursement, life insurance, EAP