Program Manager

United StatesRemote

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Responsibilities

Drive end-to-end execution of product development programs, including planning, scheduling, resource coordination, and risk management across assay, software, and systems development, ensuring alignment with regulatory and business requirements. •
Support regulatory product development activities, ensuring alignment with regulated processes and quality systems, including design control processes (ISO 13485), software lifecycle standards (IEC 62304), change management, and quality system
Coordinate regulatory submission readiness, including support for Investigational Device Exemptions (IDEs), pre-submissions, and other global regulatory filings. •
Lead cross-functional alignment across R&D, software, regulatory, quality, and clinical teams to ensure clear requirements, priorities, and deliverables. •
Identify, track and manage program risks and dependencies, proactively identifying mitigation strategies and driving issue resolution. •
Drive cross-functional accountability, influencing without direct authority to ensure alignment, ownership, and timely execution. •
Support continuous improvement of product development processes, tools, and cross-functional ways of working. •
Cultivate, build and maintain positive and collaborative relationships with cross-functional teams.

This role requires strong program management fundamentals,
experience and comfort operating in regulated environments, and the ability to coordinate complex, multi-disciplinary efforts simultaneously.
experience in program management, or equivalent combination of project management and relevant functional
experience in biotechnology, diagnostics, clinical laboratory, or life sciences. •
Experience supporting product development in regulated environments (IVD, medical device, or similar).
Background in NGS diagnostics, including assay and software components (MRD experience preferred). •
Strong familiarity with design controls (ISO 13485) and software lifecycle processes (IEC 62304). •
Experience supporting regulatory submissions (e.g., IDE, 510(k), PMA, or equivalent) preferred. •
Experience working with external partners, such as biopharma or CDx collaborations (preferred). •