Regulatory Affairs & Compliance Manager - Lab QA

SmartRecruiters, Inc.; 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 Scientific is hiring a Manager of Regulatory Affairs and Compliance to lead regulatory oversight, QA governance, and audit readiness across the DPT laboratory network.

The role requires 3–5 years in a lab with strong knowledge of CLIA, CAP, FDA, ISO standards, and policy development, with experience in training and documentation. Monday–Friday schedule with comprehensive benefits is offered.

Qualifications

• Bachelor's degree in a chemical, physical, biological science or MLS/MT from an accredited institution.
• Minimum of 3-5 years in a laboratory environment with QA/regulatory oversight.
• In-depth knowledge of regulatory standards (e.g., CLIA, CAP, FDA, ISO) and quality systems.

Responsibilities

• Oversee regulatory compliance and quality management system (QMS) alignment with applicable standards.
• Lead audits, inspections, and corrective/preventive actions.
• Maintain documentation, training programs, and KPIs to drive compliance and continuous improvement.
• Coordinate with cross-functional teams, QA, and leadership on regulatory matters.
• Interface with external regulatory bodies and clients during audits and inspections.
• Develop, revise, and implement SOPs to ensure ongoing compliance.

Skills

Attention to detail

Organization

Communication

Leadership

Problem solving

Education

Bachelor's degree in chemical/physical/biological science

MLS/MT (preferred)

Job description

Eurofins Scientific is hiring a Manager of Regulatory Affairs and Compliance to lead regulatory oversight, QA governance, and audit readiness across the DPT laboratory network.

The role requires 3–5 years in a lab with strong knowledge of CLIA, CAP, FDA, ISO standards, and policy development, with experience in training and documentation. Monday–Friday schedule with comprehensive benefits is offered.