Project Manager for CE-IVDR and supply chain at InSpace

Milpitas, California, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Oct, 26

Salary

0.0

Posted On

13 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Cross-functional Coordination, CE-IVDR, Supply Chain Management, Risk Mitigation, Milestone Tracking, Regulatory Compliance, Quality Management, Laboratory Operations, Inspection Preparedness, Stakeholder Communication, Project Reporting

Industry

Description

AccuScan Sciences is a biotechnology company developing whole-genome-sequencing-based liquid biopsy tests for minimal residual disease detection and precision oncology applications. Our work sits at the intersection of genomics and precision oncology, with a focus on advancing diagnostic capabilities that can help inform patient care and clinical decision-making. As Project Manager, you will help drive cross-functional programs that support the development and operational readiness of complex diagnostic initiatives. This role plays an important part in keeping teams aligned around shared goals, maintaining momentum across interconnected workstreams, and supporting effective coordination among scientific, operational, regulatory, and quality-focused stakeholders. 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. 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. 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 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.

Responsibilities

The Project Manager will drive cross-functional programs to support the development and operational readiness of complex diagnostic initiatives. Key duties include maintaining integrated project plans, managing CE-IVDR and supply chain timelines, and coordinating inspection preparedness.