GeneDx Benefits Overview

Owns a cross-functional IVD product development and lifecycle process across Regulatory, Quality, Product, Engineering, Procurement, and clinical laboratory teams. Responsibilities include translating requirements into Jira work, maintaining traceability matrices, coordinating design controls, risk management, V&V, design transfer, technical documentation, supplier qualification, QMS usage, and regulatory submission support. The role reports program status and risks to senior leadership and requires substantial experience in product management, laboratory operations, medical device development, and FDA-regulated environments.

Plans, leads, and delivers cross-functional EHR implementation programs from inception through completion. Manages roadmaps, resources, timelines, risks, issues, stakeholder communication, and continuous improvement while aligning multiple projects with strategic objectives. Coordinates internal and external teams, provides executive-level updates, and ensures projects are delivered on time, within budget, and within scope.

Reviews and resolves prior authorization requests, rejected authorizations, and appeals. Submits documentation to insurers, tracks outcomes, facilitates peer-to-peer reviews, and communicates with healthcare providers, insurance companies, clinical teams, billing, and market access. Maintains accurate records, monitors payer requirements, provides management updates, and supports reimbursement efforts while using authorization, CRM, and billing systems.