other
Posted 2 hours agoProgram Manager
at Natera
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.
Requirements
- 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). •