Senior Specialist, Product Safety Risk Management – Medical Device

Merative

Senior Specialist handling safety risk management for medical imaging software. Collaborating with cross-functional teams to ensure safety compliance and addressing emerging risks throughout the product lifecycle.

Posted 5/22/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $121,128 - $181,692 per yearWebsite

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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!

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

safety risk managementISO14971hazard identificationrisk analysisrisk evaluationrisk controlresidual risk assessmentFMEAsfault tree analysesbenefit-risk analyses

Soft Skills

analytical skillsproblem-solving skillsrisk-based decision-makingcollaborationinfluence without authorityorganizational skillsproject management skillsattention to detailwritten communicationverbal communication