Senior Regulatory Affairs & Compliance Manager

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

Benefits offered by this job

Medical, dental, and vision benefits

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Clinical Diagnostics is seeking a Regulatory Affairs / Compliance Manager to ensure all laboratory processes, procedures, and outputs meet defined quality and regulatory standards to maintain accreditation and deliver accurate testing results.

The role designs policies, conducts audits, manages documentation, and leads staff training to foster a culture of compliance and continuous improvement while coordinating cross-functional input with QA, operations, and leadership.

Qualifications

• Bachelor's degree in a chemical, physical, biological science, or MLS/MT.
• 3–5 years of experience overseeing QA and regulatory programs.
• In-depth knowledge of CLIA, CAP, FDA, ISO, and GxP standards.

Responsibilities

• Ensure laboratory processes and outputs meet quality and regulatory standards.
• Lead internal audits, maintain documentation, and drive corrective actions.
• Develop policies/SOPs and deliver staff training to sustain compliance.
• Coordinate with regulators and accrediting bodies for inspections and reporting.

Skills

Attention to detail

Analytical thinking

Communication skills

Leadership

Time management

Education

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

Job description

Eurofins USA Clinical Diagnostics is seeking a Regulatory Affairs / Compliance Manager to ensure all laboratory processes, procedures, and outputs meet defined quality and regulatory standards to maintain accreditation and deliver accurate testing results.

The role designs policies, conducts audits, manages documentation, and leads staff training to foster a culture of compliance and continuous improvement while coordinating cross-functional input with QA, operations, and leadership.