Project Manager for CE-IVDR and supply chain
AccuraGen · Milpitas, CA · 4 days ago
On-siteProject ManagementFull-time
Responsibilities
- Maintain integrated project plans across cross-functional teams
- Monitor deliverables and dependencies aligned to product objectives
- Ensure adherence to development timelines and escalate risks as needed
- Facilitate cross-functional project meetings and track action items
- Manage the timeline for CE-IVDR and general supply chain
- Cross-functional activities required for inspection preparedness
- Align laboratory operational readiness with accreditation and inspection timelines
- Proactively identify project risks and mitigation strategies
- Maintain clear communication across stakeholders
- Serve as central point of coordination for project-level reporting
Requirements
- Bachelor's degree required
- PMP or equivalent certification is a plus
- 3+ years of project or program management experience in biotech, diagnostics, or life sciences
- Experience with cross-functional milestone tracking and coordinating cross-functional teams required
- Experience working with laboratory operations, regulatory, and quality teams required
- Eligibility to work in the United States required
- Experience supporting CE-IVDR, and regulated laboratory environments preferred
- Experience supporting clinical development programs in oncology or molecular diagnostics preferred