SSM Health · 1 month ago
Regulatory Specialist, Lab
SSM Health is a healthcare organization dedicated to providing quality care. They are seeking a Regulatory Specialist to ensure adherence to federal and state regulations within the laboratory, performing audits and managing compliance documentation while fostering a culture of continuous improvement.
Health Care
Responsibilities
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
Qualification
Required
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
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Benefits
Paid Parental Leave: we offer eligible team members one week of paid parental leave for newborns or newly adopted children (pro-rated based on FTE).
Flexible Payment Options: our voluntary benefit offered through DailyPay offers eligible hourly team members instant access to their earned, unpaid base pay (fees may apply) before payday.
Upfront Tuition Coverage: we provide upfront tuition coverage through FlexPath Funded for eligible team members.
Company
SSM Health
SSM Health is a Catholic, not-for-profit health system.
Funding
Current Stage
Late StageRecent News
Springfield Business Journal
2026-01-05
2025-12-11
The Journal Record
2025-11-06
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