Regulatory Affairs & Compliance Leader

Eurofins Clinical Diagnostics; Centennial (WY); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Clinical Diagnostics seeks a Regulatory Affairs / Compliance Manager to ensure laboratory processes and outputs meet quality and regulatory standards. The role designs policies, conducts audits, manages documentation, and leads training to foster a culture of compliance and safety.

Responsibilities include coordinating inspections, improving QA metrics, and guiding cross-functional teams through regulatory challenges.

Qualifications

• Bachelor's degree in chemical, physical, or biological sciences.
• Minimum 3–5 years of QA/regulatory compliance experience in a lab.
• Deep knowledge of CLIA, CAP, FDA, ISO, and GxP regulations.

Responsibilities

• Oversee regulatory compliance across laboratory processes and outputs.
• Coordinate external inspections and audits with QA and leadership.
• Maintain electronic document management and training matrices.
• Develop policies/SOPs to ensure ongoing regulatory compliance.
• Deliver staff training on critical regulatory requirements.
• Lead quality improvement projects and risk assessments.
• Manage vendor due diligence and contract reviews for compliance.

Skills

Attention to detail

Organizational skills

Analytical skills

Problem-solving

Communication skills

Leadership

Time management

Education

Bachelor's degree in chemical, physical, or biological sciences (MLS/MT)

Job description

Eurofins USA Clinical Diagnostics seeks a Regulatory Affairs / Compliance Manager to ensure laboratory processes and outputs meet quality and regulatory standards. The role designs policies, conducts audits, manages documentation, and leads training to foster a culture of compliance and safety.

Responsibilities include coordinating inspections, improving QA metrics, and guiding cross-functional teams through regulatory challenges.