FDA Product Owner

GeneDx (Nasdaq: WGS) 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. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com. 

Summary   

This role supports the development and lifecycle management of GeneDx's in vitro diagnostic (IVD) products. Unlike our other Product Owners, this individual will not own a single platform. Rather, they will own a cross-functional development process spanning multiple platforms, teams, and stages of the product lifecycle. 

Positioned at the intersection of Regulatory, Quality, Product, and Development, this role translates regulatory and quality-system input into actionable engineering and development work, tracks that work to completion, and identifies and escalates gaps, dependencies, and risks before they affect the program. This is not a regulatory subject-matter-expert role; Regulatory and Quality retain ownership of interpretation. It does, however, require substantial technical proficiency, including direct work in Jira and our QMS tool, authorship and review of documentation for accuracy, and a working understanding of design controls from end to end. 

Job 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 

People Manager 

• No  

Education, Experience, and Skills 

• 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)