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Job Title: Manager, Product Safety Risk Management

Role Level: Individual Contributor

Supervisor/Manager Title: Vice President Quality and Compliance

Job Location & Environment: Irvine, CA- Corporate Office

Job Description Summary: Manager, Product Safety Risk Management is responsible for leading and advancing product safety risk management across JenaValve’s product portfolio, ensuring a consistent, compliant, and risk-based approach from concept through post-market surveillance. This role supports the product safety risk management framework and governance model, helping to drive clear, timely, and well-supported decisions across programs in alignment with ISO 14971, applicable regulatory requirements, design controls, usability engineering, and process risk management.
The Manager serves as a subject matter expert for complex product safety decisions, partners closely with cross-functional stakeholders, and contributes to audits, inspections, and regulatory interactions related to product safety. This is a manager-level individual contributor role with the opportunity to build team leadership responsibilities over time. Success in this role is reflected in effective detection and response to emerging post-market safety signals, strong quality of risk-based decisions, robust risk assessments during product development, and sustained inspection readiness.

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.
• Partners in audits, inspections, and regulatory interactions related to product safety, helping ensure sustained inspection readiness and effective response to findings and inquiries.
• Establishes and monitors meaningful metrics to assess the effectiveness of product safety risk management processes and product performance.
• Promotes a culture of patient safety, accountability, and continuous improvement.

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 Required for This Job:

• 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 operate 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.

Physical Requirements:

• Travel domestic and international up to10% time.