Program Manager (Medtech)

TL;DR

Program Manager (Medtech): Leading cross-functional programs for the development, validation, and regulatory submission of diagnostic products with an accent on regulated environments and CDx partnerships. Focus on driving execution across R&D, software, and quality teams to ensure compliant delivery of milestones.

Location: Must be based in the US; Remote with onsite engagement (up to 25% travel) at the Boulder, CO site.

Company

hirify.global is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.

What you will do

• Drive end-to-end execution of product development programs across assay, software, and systems, ensuring alignment with business and regulatory requirements.
• Support regulatory activities and ensure adherence to design control processes (ISO 13485), software lifecycle standards (IEC 62304), and quality system requirements (FDA, CAP/CLIA).
• Coordinate regulatory submission readiness, including support for IDEs, pre-submissions, and other global filings.
• Translate product strategy into actionable program roadmaps, managing timelines, milestones, and interdependencies.
• Partner with Alliance Management to coordinate joint program plans and deliverables for external biopharma and CDx partnerships.
• Manage program risks and dependencies, presenting data-driven recommendations to senior leadership for informed decision-making.

Requirements

• 3-5+ years of experience in program management within biotechnology, diagnostics, clinical laboratory, or life sciences.
• Experience supporting product development in regulated environments (IVD or medical devices).
• Background in NGS diagnostics, including assay and software components.
• Familiarity with design controls (ISO 13485) and software lifecycle processes (IEC 62304).
• Must be based in the United States.

Nice to have

• Experience supporting regulatory submissions (e.g., IDE, 510(k), PMA).
• Exposure to clinical trial operations and execution.
• Experience working with external biopharma or CDx collaborations.
• PMP or equivalent certification.

Culture & Benefits

• Comprehensive medical, dental, vision, life, and disability plans for employees and dependents.
• Free genetic testing for employees and their immediate families, including fertility care benefits.
• Pregnancy and baby bonding leave.
• 401k and commuter benefits.
• Collaborative, fast-paced environment working alongside industry elite in genetic disease management.