FDA Product Owner

GeneDx

. Support development and lifecycle management of GeneDx’s in vitro diagnostic (IVD) products across multiple platforms, teams, and lifecycle stages .

Posted 9/15/2026full-timeGaithersburg • Maryland • United StatesMid-LevelSenior💰 $140,000 - $155,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing the development and lifecycle of IVD products, ensuring compliance with regulatory standards and quality management systems. Proficient in translating product requirements into actionable tasks within Agile frameworks, while maintaining comprehensive documentation and traceability.

Highest-signal resume keywords

IVD Product ManagementRegulatory Submissions SupportRequirements Traceability MatrixJira and Confluence ProficiencyISO 13485 Familiarity

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Lab OperationsLab Report WritingProduct ManagementDesign ControlsVerification and Validation (V&V)Risk ManagementSoftware Development Life Cycle (SDLC)Cybersecurity DocumentationClinical Laboratory Improvement Amendments (CLIA)FDA Premarket Submission Experience

Soft Skills

Cross-Functional CommunicationPresentation SkillsCollaboration

Tools & Technologies

JiraConfluenceQMS ToolsKetryx

Industry Keywords

In Vitro Diagnostic (IVD)Medical Device DesignQuality Management System (QMS)FDA Quality System Regulation (QMSR)AgileScrum Master

Tech Stack

Tools & technologies

Cyber SecuritySDLC

About the role

Key responsibilities & impact

Support development and lifecycle management of GeneDx’s in vitro diagnostic (IVD) products across multiple platforms, teams, and lifecycle stages
Liaise between Regulatory, Quality, and Product/Development on initiatives with regulatory or quality-system impact
Assess impact of engineering work on requirements, design controls, risk management, V&V, design transfer, labeling, and submission documentation; track issues to resolution
Own and maintain a complete, audit-ready product-level requirements traceability matrix
Translate product-level requirements into Jira epics and stories for engineering execution
Facilitate risk management activities with Quality and maintain traceability between the Risk Management File, 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, establish testing/risk levels, and drive 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 standards 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

What you’ll need

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, including requirements, design inputs/outputs, V&V, and design reviews
Familiarity with ISO 13485 and the FDA QMSR
Experience supporting development activities that inform regulatory submissions
Software background; familiarity with SDLC concepts such as IEC 62304
Experience with Jira and Confluence; willingness to learn a QMS tool such as 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
Ability to work in both office and remote environments
Reliable high-speed internet access for remote work
Ability to sit for extended periods, up to 8 hours per day
Ability to use hands and fingers repetitively for typing and mouse operation
Visual acuity for reading computer screens and documents
Ability to communicate effectively via phone and video calls
Ability to occasionally lift up to 10 pounds

Benefits

Comp & perks

Competitive compensation and benefits reflecting local market practices and legal requirements
Hybrid work arrangement with remote work from a home office or other suitable location
Standard office equipment including computer, phone, and video conferencing tools
Reasonable accommodations for individuals with disabilities