Senior Regulatory Affairs & Compliance Leader

Eurofin; Centennial (CO); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins seeks a Manager of Regulatory Affairs and Compliance to lead regulatory oversight, quality management, and audit readiness across our laboratory operations. You will drive governance, reporting, and vendor compliance while guiding staff training and continuous improvement.

Ideal candidates bring 3–5 years of lab regulatory experience, strong knowledge of FDA/CLIA/CAP/ISO, and a Bachelor’s degree in a related field. This is a full-time on-site role offering comprehensive benefits.

Qualifications

• Bachelor's degree in a relevant science or MLS/MT background.
• 3–5 years in QA/regulatory/compliance in a lab setting.
• Strong knowledge of FDA, CLIA, CAP, ISO, GxP requirements.

Responsibilities

• Oversee regulatory oversight and alignment with accrediting bodies.
• Governance, reporting and compliance dashboards to leadership.
• Ensure vendor/third‑party compliance and due diligence.
• Lead risk assessments and incident management.
• Plan and conduct internal quality audits and CAPA processes.
• Develop and maintain policies/SOPs for ongoing compliance.
• Design training programs on regulatory requirements.
• Support business continuity and quality risk strategies.

Skills

Regulatory leadership

Quality systems

Audits & compliance

Documentation & recordkeeping

Stakeholder communication

Education

Bachelor's degree

Job description

Eurofins seeks a Manager of Regulatory Affairs and Compliance to lead regulatory oversight, quality management, and audit readiness across our laboratory operations. You will drive governance, reporting, and vendor compliance while guiding staff training and continuous improvement.

Ideal candidates bring 3–5 years of lab regulatory experience, strong knowledge of FDA/CLIA/CAP/ISO, and a Bachelor’s degree in a related field. This is a full-time on-site role offering comprehensive benefits.