Sr Specialist, Product Safety Risk Management- Medical Device

The role involves supporting the safety of medical imaging software devices through risk management processes, working closely with cross-functional teams to ensure safety compliance across the product lifecycle.

Location: Remote (US)

Salary: $121,128.00 - $181,692.00 (USD)

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.

Benefits

• Remote first / work from home culture
• Flexible vacation to help you rest, recharge, and connect with loved ones
• Paid leave benefits
• Health, dental, and vision insurance
• 401k retirement savings plan
• Infertility benefits
• Tuition reimbursement, life insurance, EAP – and more!