Manager, Regulatory Affairs and Compliance

Eurofins USA Clinical Diagnostics · Centennial

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Company
Eurofins USA Clinical Diagnostics
Location
Centennial
Employment type
Full-time
Posted
October 9, 2026

About this job

GENERAL JOB DESCRIPTION The Regulatory Affairs / Compliance Manager is responsible for ensuring that all laboratory processes, procedures, and outputs meet defined standards of quality and regulatory compliance. This role is critical in maintaining accreditation and delivering accurate and reliable testing results. The Manager designs and implements policies and procedures, conducts regular audits, manages documentation, and leads staff training initiatives to foster a culture of compliance and maintain the highest standards of quality and safety. This role coordinates cross-functional input. KEY RESPONSIBILITIES Regulatory Oversight: Ensures alignment with relevant regulatory / accrediting bodies (e.g., FDA, CLIA, CAP, ISO, ASHI, etc.) Monitors effectiveness of the QMS through internal…

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