Regulatory Compliance Coordinator

The Donor Network Inc•Miami Lakes, FL

About The Position

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.

Requirements

Bachelor's degree in physical sciences or quality studies is required. Equivalent work experience may be substituted for education.
Four to six years of auditing experience in regulated or certified industry.
Proficient with Microsoft office suite.

Nice To Haves

Experience working with an Organ Procurement Organization is preferred.
Knowledge of Q-pulse or other quality management software preferred.
ASQ certification preferred; years of experience may be considered in lieu of certification. Certification must be obtained within 18 months of employment.
Knowledge of human anatomy and medical terminology is preferred.
Experience with electronic medical records is preferred.

Responsibilities

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.
Identifying processes for audit, including 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, and SFDN’s regulatory and accrediting agency audit CAPA responses.
Assisting the Manager of Quality & Regulatory Affairs (MQRA) with developing an annual audit schedule.
Ensuring audits (self-assessments) required by accrediting bodies are completed within prescribed time frames.
Conducting 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, and effectiveness checks are performed to ensure ongoing compliance with the implemented CAPAs.
Serving as a resource for the development of corrective actions to address observations and findings.
Assisting the MQRA with preparing for and facilitating external audits in accordance with established SOPs.
Ensuring audits are initiated, conducted, and documented within the quality management software audit module, including the initiation of an occurrence reports for all audit findings.
Assisting with the development and completion of regulatory and accrediting agency gap assessment tools.
Meeting with respective department management and staff to collaboratively complete gap assessments.
Assisting with addressing all gaps identified to ensure SFDN’s establishes compliance.
Monitoring and analyzing changes in legislation and accreditation standards that affect SFDN’s operations, including, but not limited to, those of CMS, UNOS, ASHI.
Performing monitoring, review, and ensuring completion of vendor or supplier qualifications required for compliance with regulatory and accrediting agencies. Recommending actions for vendors or suppliers that do not maintain compliance requirements or have a high complaint and/or occurrence rate.
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.
Maintaining all existing licensure or registrations ensuring they are current. Assisting the MQRA with new applications for licensure or registration including, and not limited to, the completion of re-accreditation applications and pre-inspection checklists.
Working with Quality & Regulatory Affairs staff to ensure completion of donor record audits, DRAI recording audits, and authorization recording audits. Assisting the MQRA and MQRA with ensuring these audits meet both the needs of the department and are conducted in a manner which ensures regulatory compliance of documentation of the donation event.
Tracking and trending audit findings to assist departmental management in identifying opportunities for improvement (OFIs).
Initiating and participating in PDSAs and other quality improvement projects.
Assisting with validation activities for new equipment, re-qualification of existing equipment, software verification, etc. to include written validation protocols, written validation reports, and re-qualification or addendum reports when required.
Assisting the MQRA with the monitoring asset program in the quality management software to ensure SFDN’s equipment files are accurate and that all maintenance, calibrations, cleaning, etc. are completed as required.
Conducting audits to ensure SFDN maintains compliance with the established equipment program.
As needed, assisting the Quality & Regulatory Affairs department with the occurrence reporting system and conducting Death Record Reviews in accordance with established procedures.
Serving as a resource to departmental management in reviewing proposed revisions to policies, procedures, and forms to determine regulatory compliance prior to implementation.
Serving as a Quality & Regulatory Affairs department resource in conducting Root Cause Analysis of reported occurrences, audit findings, etc. and providing reports of this analysis in accordance with established policy.
Other duties as assigned.
Adhering to and remaining in full compliance with SFDN’s Motor Vehicle Driving Policy as outlined in the Motor Vehicle Records and Driver Safety policy PC.334.