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) 

• CLIA-regulated laboratory experience 

• Cybersecurity documentation experience for medical device submissions 

Certificates, Licenses, Registrations 

• None  

Work Environment 

 
This is a hybrid position requiring both in-office and remote work. The employee will work from our 

office location in Gaithersburg, MD and remotely from a home office or other suitable location with reliable high-speed internet access. In-office work is performed in a professional office setting with standard lighting, temperature control, and low to moderate noise levels. Remote work is performed in a climate-controlled environment. Standard office equipment including computer, phone, and video conferencing tools are used in both settings. Your standard work schedule and hours will be established in collaboration with your leader and may be adjusted to align with evolving business needs. 

Physical Demands 

This is a sedentary role requiring prolonged periods of sitting while working at a computer. Physical demands include: 

• Sitting for extended periods (up to 8 hours per day) 

• Repetitive use of hands and fingers for typing and mouse operation 

• Visual acuity for reading computer screens and documents 

• Ability to communicate effectively via phone and video calls 

• Occasional lifting of up to 10 pounds (office supplies, equipment) 

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. 

Acknowledgements 

The above job description is not intended to be an all-inclusive list of duties and standards of the position.  Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.