Regulatory Compliance Coordinator

This position is responsible for monitoring and analyzing current and impending regulations and standards, 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 NDN 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. Responsibilities Responsible for conducting internal audits per the established audit schedule to ensure NDN’s compliance to all state, federal, and accrediting agency regulations, and standards and NDN 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. NDN regulatory and accrediting agency audit CAPA responses Assist the Director of Quality & Regulatory Affairs (DQRA) 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 NDN 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 DQRA with preparing for and facilitating external audits in accordance to 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 NDN establishes compliance Responsible for monitoring and analyzing changes in legislation and accreditation standards that affect NDN’s operations including but not limited to those of FDA, CMS, UNOS, AOPO, AATB, ASHI, and EBAA. 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 DQRA 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 DQRA 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 recording audits, and authorization recording audits. Assist the DQRA 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. Track and trend audit findings to assist departmental management in identifying opportunities for improvement (OFIs). Initiates and participates PDSAs and other quality improvement projects. Will assist 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. Responsible for assisting the DQRA with the monitoring the asset program in the quality management software to ensure NDN equipment files are accurate and that all maintenance, calibrations, cleaning, etc. are completed as required. Conducts audits to ensure NDN maintains compliance with the established equipment program. As needed, assists the Quality & Regulatory Affairs department with the occurrence reporting system and conducting Death Record Reviews in accordance to established procedures. Serve as a resource to departmental management in reviewing proposed revisions to policies, procedures, and forms to determine regulatory compliance prior to implementation. Serves 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 to established policy Other duties as assigned. Qualifications Education: Bachelor's Degree in physical sciences or quality studies is required. Equivalent work experience may be substituted for education. Required Skills Four to six years auditing experience in regulated or certified industry. Preferred Skills Experience working with an Organ Procurement Organization or Tissue Recovery/Processing facility is preferred. Computer Skills: Proficient with Microsoft office suite. Knowledge of Q-pulse or other quality management software preferred. Certificates & Licenses: ASQ certification preferred; years of experience may be considered in lieu of certification. Certification must be obtained within 18 months of employment. Other Requirements: Knowledge of human anatomy and medical terminology is preferred. Experience with electronic medical records is preferred. Pay range and compensation package Pay range or salary or compensation Equal Opportunity Statement Include a statement on commitment to diversity and inclusivity. #J-18808-Ljbffr