Sr Specialist, Product Safety Risk Management

Merative seeks a Senior Specialist, Product Safety Risk Management to support the safety of regulated and non-regulated medical imaging software devices. The role owns and applies risk management processes across the product lifecycle, partnering with cross-functional teams to identify, evaluate, control, and monitor safety risks and 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, in accordance with defined processes
• 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:

o   21 CFR Part 820 Quality System Regulation

o   Canada Medical Devices Regulations (SOR/98-282)

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