Manager, Product Safety Risk Management

Job Responsibilities

Leads execution of 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.

Develops, implements, and continuously improves policies, procedures, templates, tools, and quality system controls that enable effective and scalable product safety risk management.

Provides product safety risk management leadership for complex programs, supporting cross-functional teams with timely, risk-based decision making, escalation, and resolution.

Ensures product safety risk management is integrated with design controls, software development lifecycles, usability engineering, process 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 support effective monitoring of product risk performance.

Contributes product safety risk management content for regulatory submissions, design changes, and product lifecycle assessments.

Promotes a culture of patient safety, accountability, and continuous improvement.

Qualifications

Required Education and Experience: 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 across pre-market and post-market phases, including experience with risk management processes and governance.

Strong understanding of design controls and their integration with usability engineering, and post-market surveillance.

Proven ability to influence senior stakeholders, lead cross-functional decision making, and communicate complex risk issues with clarity and judgment.

Experience leading initiatives or mentoring others in product safety risk management or closely related quality and regulatory functions is preferred.

Skills And Abilities

Advanced knowledge of applicable standards and regulations, including ISO 13485, 21 CFR Part 820, and EU MDR 2017/745.

Strong working knowledge of risk management methods and deliverables, including hazard analysis, FMEA, fault tree analysis, benefit-risk analysis, and residual risk evaluation.

Experience with quality systems, product development processes, and enabling technologies or work management platforms that support product lifecycle and risk management activities.

Leadership Competencies

Exercises sound judgment and operates effectively with a high degree of independence in a complex environment.

Drives accountability, collaboration, and continuous improvement across functions while maintaining a strong focus on patient safety and product quality.

Demonstrates leadership through influence, partnership, and effective communication across levels of the organization.