FDA Product Owner

Responsibilities

• Liaise between Regulatory, Quality, and Product/Development on initiatives with regulatory or quality-system impact
• Assess impact when engineering work touches requirements, design controls, risk management, V&V, design transfer, labeling, or submission documentation, and track to resolution
• Own the product-level requirements traceability matrix, keeping it complete and audit-ready
• Translate product-level requirements into Jira epics/stories for engineering execution
• Facilitate risk management activities with Quality, keeping the Risk Management File traceable to requirements and design outputs
• Coordinate technical documentation, including design control records, test protocols/reports, and labeling/IFU inputs
• Lead design transfer from test/dry-lab to wet lab, setting testing/risk levels and driving toward sign-off
• Serve as technical point of contact with Procurement and Quality on supplier qualification
• Maintain organized documentation across QMS tools, Jira, and Confluence
• Set the standard for consistent QMS tool usage across Product Owners
• Coordinate with the clinical lab on investigations alongside the relevant platform Product Owner
• Report status and risk to senior leadership

Requirements

• Bachelor's degree required; advanced degree (MBA, MPH, MS) or clinical training is a plus
• 6+ years of experience in lab operations and lab report writing processes and systems
• 6+ years of product management experience, including 2+ years in lab enterprise or clinician-facing tools and applications
• Demonstrated IVD/medical device design and development experience — requirements, design inputs/outputs, V&V, design reviews
• Familiarity with ISO 13485 and the FDA QMSR
• Experience supporting development activities that inform regulatory submissions
• Software background; familiarity with SDLC concepts (e.g., IEC 62304)
• Experience with Jira and Confluence; willingness to learn a QMS tool (e.g., Ketryx)
• Experience building or maintaining a requirements traceability matrix
• Strong cross-functional communication, including presenting to senior leadership
• Product Owner, Agile, or Scrum Master experience
• Experience supporting an FDA premarket submission (510(k), PMA, or De Novo)
• CLIA-regulated laboratory experience
• Cybersecurity documentation experience for medical device submissions

About the Company

GeneDx delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care.