Senior Product Safety Risk Manager (SaMD, ISO 14971)

Merative; Oregon; Hybrid; USD 121,000 - 182,000; Full time

Benefits offered by this job

Remote first

Flexible vacation to help you rest, re

Paid leave benefits

Health, dental, and vision insurance

401k retirement savings plan

Infertility benefits

Tuition reimbursement, life insurance,

Job summary

Merative in the United States is seeking a Senior Specialist, Product Safety Risk Management to own ISO 14971-based risk management for medical imaging software devices across the lifecycle. You will collaborate with engineering, clinical, cybersecurity, human factors, and regulatory affairs to identify and control safety risks.

The role emphasizes developing risk management files, supporting post-market safety activities, CAPA, and regulatory submissions while promoting patient safety and

Qualifications

• 5+ years of safety risk management experience in healthcare technology or regulated industries, preferably involving SaMD.
• Practical experience applying ISO14971 to software-based medical devices across pre-market and post-market phases.
• Strong understanding of design controls and their integration with safety risk management activities.
• Excellent analytical, problem-solving, and risk-based decision-making skills.

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.

Education

Bachelor's degree in engineering, computer science, life sciences, or equivalent

Tools

Jira

Xray Test Management

Microsoft 365

Job description

Merative in the United States is seeking a Senior Specialist, Product Safety Risk Management to own ISO 14971-based risk management for medical imaging software devices across the lifecycle. You will collaborate with engineering, clinical, cybersecurity, human factors, and regulatory affairs to identify and control safety risks.

The role emphasizes developing risk management files, supporting post-market safety activities, CAPA, and regulatory submissions while promoting patient safety and