8-10 years of progressive experience in medical device or healthcare technology, including significant responsibility for product safety risk management in regulated environments.
Demonstrated expertise applying ISO 14971 to software-based medical devices across pre-market and post-market phases, including governance of risk management processes.
Strong understanding of design controls and their integration with usability engineering, cybersecurity risk management, software development lifecycles, and post-market surveillance.
Proven ability to influence senior stakeholders, lead cross-functional decision making, and communicate complex risk issues with clarity and judgment.
Demonstrated experience leading, managing, or developing professionals in safety risk management or closely related quality and regulatory functions.
Technical Skills
Advanced knowledge of related standards and regulations, including ISO 13485, IEC 62304, IEC 62366-1, 21 CFR Part 820, the Canada Medical Devices Regulations, and EU MDR 2017/745.
Experience supporting Software as a Medical Device and modern software development environments, including agile methodologies and cloud-based solutions.
Relevant advanced training or certification in medical device risk management, quality systems, or regulatory affairs.
Experience with enabling technologies and work management platforms such as Jira, Aha!, Xray Test Management, and Microsoft 365 preferred.
Supervisory Skills
Builds and develops high-performing teams through clear expectations, coaching, performance feedback, and career development.
Exercises sound judgment and operates effectively with a high degree of independence in a complex, matrixed environment.
Drives accountability, collaboration, and continuous improvement ac
Benefits
Health insurance
Additional Information
Merge medical imaging solutions, offered by Merative, combine intelligent, scalable imaging workflow tools with deep and broad expertise to help healthcare organizations improve their confidence in patient outcomes and optimize care delivery.
The Senior Manager, Product Safety Risk Management provides enterprise leadership for product safety risk management across the medical imaging software portfolio, ensuring a consistent, compliant, and risk-based approach from concept through post-market surveillance. This role owns the product safety risk management framework, establishes governance and decision quality across programs, and ensures alignment with ISO 14971, applicable regulatory requirements, design controls, usability engineering, and cybersecurity risk management.
In addition to leading and developing safety risk management professionals, the Senior Manager serves as the senior subject matter expert for high-risk and complex product decisions, influences senior cross-functional stakeholders, and represents the organization in audits, inspections, and regulatory interactions related to product safety. Success in this role is reflected in sustained inspection readiness, timely and high-quality risk decisions, and effective detection and response to emerging post-market safety signals.
Essential Job Duties
Owns the product safety risk management framework and governance model, ensuring consistent application of ISO 14971-aligned practices across the portfolio and throughout the product lifecycle.
Defines, implements, and continuously improves policies, procedures, templates, tools, and quality system controls that enable effective and scalable product safety risk management.
Leads safety risk strategy for medical imaging portfolio and complex programs, providing decision support to cross-functional leaders and ensuring timely, risk-based escalation and resolution.
Ensures product safety risk management is fully integrated with design controls, software development lifecycles, usability engineering, cybersecurity risk management, verification and validation, and post-market surveillance.
Oversees the quality and completeness of risk management files and related documentation, including hazard analyses, FMEAs, fault tree analyses, benefit-risk analyses, residual risk evaluations, and Health Hazard Evaluations.
Leads post-market safety activities, including safety signal assessment, Health Hazard Evaluations, CAPAs, and cross-functional response planning, to ensure effective monitoring of product risk performance.
Contributes product safety risk management content for regulatory submissions, design changes, and product lifecycle assessments.
Serves as the primary product safety risk management leader for audits, inspections, and regulatory interactions, ensuring sustained inspection readiness and effective response to findings and inquiries.
Builds organizational capability by leading and developing talent, and establishing performance metrics to monitor the effectiveness of product safety risk management processes and product performance.
Promotes a culture of patient safety, accountability, and continuous improvement.
Merative · Remote