Regulatory & Quality Compliance Leader

Eurofins Clinical Diagnostics; Centennial (CO); Presencial; USD 100.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Descripción de la vacante

Eurofins USA Clinical Diagnostics is seeking a Regulatory Affairs / Compliance Manager to ensure laboratory processes meet quality and regulatory standards. The role leads audits, policy development, staff training, and documentation across the DPT network, coordinating with regulatory bodies and vendors.

The position requires a bachelor’s degree in a chemical/biological science or MLS/MT and 3–5 years of QA/regulatory experience, with strong attention to detail and leadership skills.

Formación

• Education: Bachelor's degree in a chemical, physical, biological science, or MLS/MT.
• Experience: 3–5 years in a laboratory environment with QA/regulatory exposure.
• Knowledge: FDA, CLIA, CAP, ISO, GxP and related quality systems.

Responsabilidades

• Regulatory oversight and liaising with FDA, CLIA, CAP, ISO, and other bodies.
• Lead internal quality audits and manage CAP/ISO readiness.
• Develop and implement SOPs, training, and document control processes.
• Report to leadership with compliance dashboards and risk metrics.
• Support business continuity and vendor compliance initiatives.

Conocimientos

Attention to detail

Analytical skills

Communication skills

Leadership

Time management

Educación

Bachelor's degree in a chemical, physical, biological science, or MLS/MT

Descripción del empleo

Eurofins USA Clinical Diagnostics is seeking a Regulatory Affairs / Compliance Manager to ensure laboratory processes meet quality and regulatory standards. The role leads audits, policy development, staff training, and documentation across the DPT network, coordinating with regulatory bodies and vendors.

The position requires a bachelor’s degree in a chemical/biological science or MLS/MT and 3–5 years of QA/regulatory experience, with strong attention to detail and leadership skills.