🛠 Tech Stack

💼 About This Role

You'll lead cross-functional product development programs in diagnostic products at a global leader in cell-free DNA testing. You'll drive execution from strategy to delivery, coordinating R&D, software, regulatory, and external partners. This role offers the chance to shape companion diagnostic partnerships in a regulated, fast-paced environment.

🎯 What You'll Do

• Drive end-to-end execution of product development programs, including planning, scheduling, and risk management.
• Coordinate regulatory submission readiness and support global filings (IDE, pre-submissions).
• Lead cross-functional alignment across R&D, software, regulatory, quality, and clinical teams.
• Manage external biopharma and CDx partnerships, coordinating joint program plans and deliverables.

📋 Requirements

• 3-5+ years in program management in biotechnology, diagnostics, or life sciences.
• Experience supporting product development in regulated environments (IVD, medical device).
• Background in NGS diagnostics including assay and software components.
• Strong familiarity with design controls (ISO 13485) and software lifecycle processes (IEC 62304).

✨ Nice to Have

• Experience supporting regulatory submissions (IDE, 510(k), PMA).
• Exposure to clinical trial operations.
• PMP or equivalent certification.

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Panel Interview· 60 min