Manager, Product Safety Risk Management
About The Position
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.
Requirements
- 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.
- 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.
- 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.
Nice To Haves
- Experience leading initiatives or mentoring others in product safety risk management or closely related quality and regulatory functions is preferred.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
