Merative is a company focused on healthcare technology, and they are seeking a Principal, Product Safety Risk Management. This role involves providing technical leadership in product safety risk management for medical imaging software devices, ensuring compliance with safety regulations and driving continuous improvement in safety practices.

Responsibilities:

Provides expert technical leadership for safety risk management activities in conformance with applicable regulations, standards, and guidance, including ISO 14971, ensuring consistent and effective implementation across assigned products, programs, and lifecycle phases
Leads complex risk management analyses and documentation activities, including hazard identification, risk analysis, risk evaluation, risk control strategy, residual risk acceptability, benefit-risk assessment, and risk management report conclusions
Serves as a principal technical advisor to product development and quality teams, influencing design controls, architecture decisions, product requirements, verification and validation strategy, and release readiness decisions within assigned programs
Interprets and applies complex safety-related regulations, standards, guidance, and internal QMS procedures, and provides expert guidance to cross-functional stakeholders on risk-based decision-making and regulatory expectations
Develops, maintains, reviews, and approves risk management files and associated documentation, including hazard analyses, FMEAs, fault tree analyses, benefit-risk analyses, risk management plans, and risk management reports
Integrates clinical, human factors/usability, cybersecurity, interoperability, and post-market evidence into safety risk management practices, including use-related and security-related hazards
Evaluates risk control effectiveness and ensures robust traceability to requirements, verification, validation, usability, clinical, cybersecurity, and post-market evidence
Provides senior expert review for post-market safety activities, including Health Hazard Evaluations (HHEs), complaint investigations, field safety corrective actions, post-market surveillance trending, and escalation of emerging safety signals
Identifies systemic or emerging safety risks, assesses patient safety and product impact, and recommends risk-based corrective and preventive actions in collaboration with quality, regulatory, product, and engineering partners
Develops and interprets safety and risk-related quality metrics to support management review, quality planning, audit readiness, and continuous improvement priorities
Leads technical contributions to regulatory submissions, change assessments, design history documentation, and regulatory responses, ensuring alignment with applicable regulatory expectations and product claims
Applies advanced problem-solving methodologies to ambiguous or high-impact safety issues, facilitates alignment across stakeholders, and clearly communicates risk-based recommendations to technical and leadership audiences
Mentors and guides less experienced team members and cross-functional partners on product safety risk management principles, documentation expectations, and regulatory defensibility
Promotes a culture of patient safety, risk awareness, collaboration, quality ownership, and continuous improvement across the organization
Supports internal audits, external audits, inspections, and management discussions as a senior subject matter expert, providing objective evidence, technical rationale, and regulatory justification as required

Requirements:

Minimum of 8 years of progressive experience in safety risk management, quality, regulatory affairs, systems engineering, clinical safety, or related disciplines within healthcare technology, medical devices, or other regulated industries, preferably involving Software as a Medical Device (SaMD)
Extensive practical experience applying ISO 14971 to software-based medical devices across pre-market and post-market phases, including post-market feedback, risk management file updates, residual risk assessment, benefit-risk evaluation, and regulatory submission support
Deep understanding of design controls and demonstrated ability to integrate safety risk management into product architecture, requirements, verification and validation, usability, cybersecurity, and release decision-making
Advanced analytical, problem-solving, and risk-based decision-making skills, including the ability to resolve ambiguous, complex, or high-impact product safety issues
Proven ability to influence cross-functional stakeholders without direct authority, drive alignment, and make recommendations that balance patient safety, regulatory expectations, product performance, and business priorities
Strong prioritization, technical leadership, and change management skills, with the ability to support multiple complex initiatives while maintaining quality, traceability, and regulatory defensibility
Excellent written and verbal communication skills, including the ability to prepare clear technical rationale, executive-ready summaries, audit responses, and regulator-facing documentation
Demonstrated ability to work independently with broad latitude, exercise sound judgment, mentor others, and serve as an escalation point for complex safety risk management matters
Expert-level knowledge of ISO 14971 and its application to medical device software, including complex software, interoperability, cybersecurity, usability, clinical workflow, and post-market risk considerations
Advanced working knowledge of related standards and expectations, including ISO 13485, IEC 62304, IEC 62366-1, and applicable software, cybersecurity, usability, and post-market surveillance guidance
Strong knowledge of applicable regulatory frameworks, including 21 CFR Part 820 Quality System Regulation, Canada Medical Devices Regulations (SOR/98-282), and EU Medical Device Regulation (EU) 2017/745
Strong familiarity with software development lifecycles, including agile methods, risk-based testing, issue management, release readiness, 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 degree in engineering, life sciences, health sciences, regulatory affairs, quality, or a related discipline preferred
Advanced training or certification in medical device safety risk management, quality, regulatory affairs, systems engineering, or related discipline preferred
Experience with agile development environments, cloud-based solutions, regulated medical device software, and global regulatory expectations preferred

IT Risk Management

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