Senior Specialist, Product Safety Risk Management – Medical Device

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 (Sa MD).
• 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.
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