The opportunity
Location: Remote or On-Site in Boulder, CO (Foresight Dx business unit, a Natera company)
What you'll do
Lead complex, cross-functional product development programs and serve as the: program leader for core teams across R&D, Software, Quality, Regulatory, Clinical, and Operations.
Drive programs through key development milestones, design reviews, phase: exits, clinical trial launch, FPI, and regulatory submission.
Translate product goals and regulatory requirements into clear plans,: priorities, and decisions that enable teams to execute.
Bring cross-functional teams together to resolve technical, operational, and: organizational issues and keep programs moving forward.
Identify and manage program risks, dependencies, and trade-offs, escalating: issues and driving decisions through a formal portfolio governance process when needed. Communicate program progress, risks, decisions, and recommendations to functional and senior leadership.
Partner with development teams to ensure product requirements, design: controls, risk management, verification/validation, and documentation are appropriately planned and executed.
What they're looking for
- Author and review key product development deliverables, including DDPs, DHF: documentation, design review materials, change orders, and other development documentation.
- Support preparation and execution of IDE, IVDR, 510(k), and other regulatory: submissions by coordinating cross-functional deliverables and submission readiness.
- For CDx programs, partner with CDx development and biopharma partnership: teams to align clinical trial assay activities with the broader CDx strategy.
- Apply strong knowledge of ISO 13485, IEC 62304, design controls, and: regulated product development to identify gaps, anticipate risks, and help teams make sound decisions.
