Principal Program Manager, IVD

Principal Program Manager (IVD Core Team Lead)Location: Remote, San Diego, CA or Madison, WIOverviewWe are seeking a highly experienced Senior / Principal Program Manager to lead a mission-critical initiative supporting its blood-based cancer detection product. This role will drive the transition from a Laboratory Developed Test (LDT) to an FDA-regulated In Vitro Diagnostic (IVD) submission (PMA/510k).This position represents a top strategic priority for the organization and requires a proven program leader with deep expertise in FDA-regulated medical device development, design controls, and end-to-end submission ownership.Role SummaryThis individual will serve as the IVD Core Team Lead, owning end-to-end program execution for FDA submission activities. The role operates within Product Management and leads cross-functional efforts in a highly matrixed environment without direct reports.The ideal candidate is a strong program leader who can operate across both strategic planning and detailed execution phases while driving alignment across complex, regulated workflows.Key ResponsibilitiesOwn end-to-end program leadership for FDA-regulated diagnostic product submission (PMA/510k)Lead cross-functional core team execution across R&D, Regulatory, Quality, Clinical, and ManufacturingDrive integrated program planning, including timelines, resource allocation, and milestone trackingLead and enforce Design Control processes, including:Design reviews and stage-gate processesTraceability matrix development and maintenanceDesign inputs, outputs, and V&V alignmentOwn risk management strategy and execution, including maintenance of Risk Management Files (ISO 14971)Drive decision-making processes, including maintaining decision logs and facilitating cross-functional alignmentIdentify, assess, and mitigate program risks and issues proactivelyManage both early-stage planning (high upfront structuring) and execution phases (ongoing program operations)Ensure readiness and coordination for FDA submission activities, including documentation and cross-functional deliverablesProvide clear, consistent updates to leadership and stakeholdersRequired Qualifications (Non-Negotiable)5+ years of program/project management experience in FDA-regulated medical devicesDirect experience leading end-to-end FDA submissions (PMA and/or 510k) — not limited to post-market supportStrong expertise in Design Controls (21 CFR Part 820 / ISO 13485)Hands-on experience with:Traceability matricesRisk management files (ISO 14971)Design reviews and stage gatesDemonstrated program leadership experience, including:Integrated planningResource planningRisk and issue trackingExperience working in cross-functional, matrixed environmentsPreferred QualificationsExperience with In Vitro Diagnostics (IVD)Experience in oncology, cancer diagnostics, or screening productsBackground in blood-based diagnostics or similar technologiesExperience with complex, high-visibility regulatory submissionsPMP or equivalent certification