Biotech Project Manager - CE-IVDR & Supply Chain

AccuScan Sciences; Milpitas (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

AccuScan Sciences in Milpitas, CA is seeking a Project Manager to drive cross-functional programs that support the development and operational readiness of complex diagnostic initiatives.

You will align scientific, regulatory, quality, and operational teams, maintain integrated plans, monitor milestones, and coordinate inspections and CE-IVDR readiness to ensure successful program delivery.

Qualifications

• 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.
• Experience with laboratory operations, regulatory, and quality teams; eligible to work in the United States.
• Experience supporting CE-IVDR and regulated laboratory environments preferred.

Responsibilities

• Maintain integrated project plans across cross-functional teams.
• Monitor deliverables and dependencies aligned to product objectives.
• Ensure adherence to development timelines and milestones.
• Facilitate cross-functional project meetings and track action items.
• Manage the timeline for CE-IVDR and general supply chain.
• Coordinate 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.

Skills

Cross-functional milestone tracking

Laboratory operations experience

Regulatory and quality coordination

Project management

Communication and collaboration

Education

Bachelor’s degree

PMP certification

Job description

AccuScan Sciences in Milpitas, CA is seeking a Project Manager to drive cross-functional programs that support the development and operational readiness of complex diagnostic initiatives.

You will align scientific, regulatory, quality, and operational teams, maintain integrated plans, monitor milestones, and coordinate inspections and CE-IVDR readiness to ensure successful program delivery.