Regulatory Specialist, Lab

Job Summary

Under general direction, responsible for ensuring adherence to federal and state regulations related to quality and personnel qualifications. Performs audits, investigates non-compliance, and provides guidance to cross‑functional teams to address regulatory issues or risk. Manages documentation, auditing practices, regulatory training, and fosters a culture of continuous improvement within the laboratory.

• Assesses adherence to relevant Joint Commission, CAP, CLIA, CMS and FDA regulations, standards, and internal policies to ensure a safe and compliant laboratory environment.
• Maintains and updates regulatory documentation, processes, and procedures to align with evolving guidelines and industry best practices.
• Leads comprehensive on‑site surveys and audits to evaluate compliance levels, identifying areas for improvement as needed.
• May manage FACT accreditation, Donor Manufacturing Audits and National Marrow Donor Program responsibilities where applicable.
• Investigates and resolves complaints and non‑compliance events, utilizing root cause analysis frameworks to prevent recurrence.
• Develops and delivers training programs for laboratory personnel on compliance and safety standards, enhancing their understanding and capability in maintaining regulatory requirements.
• Prepares clear and comprehensive reports delineating findings, deficiencies, and recommendations for corrective actions based on audit results and investigations.
• Gathers and analyzes data related to compliance performance metrics, communicating findings to key stakeholders.
• Stays informed of changes in regulations and industry standards, ensuring documentation and training materials are kept up‑to‑date and laboratory is inspection ready at all times.
• Utilizes performance improvement methodologies (e.g., A3 thinking, PDCA, value stream mapping) to drive quality management system enhancements and ongoing process improvement.
• Works effectively within a multidisciplinary team, facilitating communication between various departments, vendors, and regulatory bodies to ensure organizational compliance.
• Performs other duties as assigned.

Bachelor's degree in Science, Medical Laboratory Science, Biology or Chemistry or equivalent years of experience and education.

Two years' experience in a laboratory setting.

• Frequent lifting/carrying and pushing/pulling objects weighing 0‑25 lbs.
• Frequent sitting, standing, walking, reaching and repetitive foot/leg and hand/arm movements.
• Frequent use of vision and depth perception for distances near (20 inches or less) and far (20 feet or more) and to identify and distinguish colors.
• Frequent use of hearing and speech to share information through oral communication; ability to hear alarms, malfunctioning machinery, etc.
• Frequent keyboard use/data entry.
• Occasional bending, stooping, kneeling, squatting, twisting and gripping.
• Occasional lifting/carrying and pushing/pulling objects weighing 25‑50 lbs.
• Rare climbing.

State of

Work Location:

Illinois, Missouri, Oklahoma, Wisconsin.

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