Regulatory Compliance Coordinator

POSITION SUMMARY

This position is responsible for monitoring and analyzing current and impending regulations and standards, and conducting and facilitating internal and external audits. The Regulatory Compliance Coordinator will assist with the development and implementation of Corrective and Preventive action (CAPA) plans and conducting Effectiveness Checks. Assists with ensuring compliance to state, federal and accrediting agency regulations, and standards as well as South Florida Donor Network, Inc.

(SFDN)’s standard operating procedures (SOPs). This position is also responsible for technical development of personnel, leading others through audits, ensuring audit deliverables, and maintaining the quality management software audit, asset, and supplier programs. The Regulatory Compliance Coordinator will assist with the equipment program and validation activities for equipment, applicable software verification, and any other validation and qualification tasks.

Essential Functions Statement(s):

• Responsible for conducting internal audits per the established audit schedule to ensure SFDN’s compliance to all state, federal, and accrediting agency regulations and standards and SFDN’s SOPs, and assisting with conducting and facilitating external audits.
• Identify processes for audit, to include:
• those required by regulatory bodies or accrediting agencies.
• processes having undergone significant revision.
• effectiveness assessments of corrective and preventive action plans.
• those processes with a significant number of failure points.
• SFDN’s regulatory and accrediting agency audit CAPA responses.
• Assist the Manager of Quality & Regulatory Affairs (MQRA) with developing an annual audit schedule.
• Ensures audits (self‑assessments) required by accrediting bodies are completed within prescribed time frames.
• Conducts audits in accordance to established SOPs ensuring:
• Audits are scheduled, conducted, and documented within the quality management software audit program including the initiation of an occurrence report for all audit findings.
• Use of audit assessment checklists which will assess compliance of written policy against regulation and current practice against written policy.
• Audit reports are written and provided to SFDN’s Leadership and Management
• Timely receipt and closure of CAPA responses
• Effectiveness checks are performed to ensure ongoing compliance with the implemented CAPAs
• Serves as a resource for the development of corrective actions to address observations and findings.
• Assist the MQRA with preparing for and facilitating external audits in accordance with established SOPs.
• Audits are initiated, conducted, and documented within the quality management software audit module, including the initiation of an occurrence reports for all audit findings.
• Assist with the development and completion of regulatory and accrediting agency gap assessment tools
• Meet with respective department management and staff to collaboratively complete gap assessments
• Assist with addressing all gaps identified to ensure SFDN’s establishes compliance
• Responsible for monitoring and analyzing changes in legislation and accreditation standards that affect SFDN’s operations, including, but not limited to, those of CMS, UNOS, ASHI.
• Performs monitoring, review, and ensures completion of vendor or supplier qualifications required for compliance with regulatory and accrediting agencies. Will recommend actions for vendors or suppliers that do not maintain compliance requirements or have a high complaint and/or occurrence rate.
• Responsible for assisting the MQRA with maintaining the supplier program in the quality management software, ensuring all vendors are entered accurately, categorized, and all relevant documentation (qualification surveys, licenses, registrations, etc.) is attached.
• Maintains all existing licensure or registrations ensuring they are current. Assists the MQRA with new applications for licensure or registration including, and not limited to, the completion of re‑accreditation applications and pre‑inspection checklists.
• Work with Quality & Regulatory Affairs staff to ensure completion of donor record audits, DRAI…