The Director of Regulatory Affairs oversees the daily operations of the Regulatory Affairs Department across the health care setting and ensures that compliance and patient safety goals of the System are met by performing and managing regulatory, accreditation, quality, risk and performance improvement activities, and developing optimal strategies throughout the regulatory process.
Responsibilities
Serves as a proactive change agent promoting regulatory readiness, and assists in the integration of standards and requirements into the department. Ensures the delivery of patient-centered, cost-effective, quality services across the continuum of care, optimal utilization of resources and ongoing compliance with applicable local, state, federal rules, regulations and security standards.
Provides strategic regulatory leadership and leads the day-to-day operations of the department and regulatory and compliance programs, following guidelines and regulatory requirements and monitors the overall effectiveness of the program and departmental activities.
Partners with senior leadership and other key stakeholders to define the strategic direction and operational plan for advancing regulatory and compliance programs, ensuring alignment with the System’s mission, values, and business goals.
Develops and implements quality assurance initiatives and related services to ensure compliance with regulatory mandates, and establishes program and service goals and priorities.
Investigates and reviews regulatory complaints and other related issues and coordinates correction and/or resolution, conducting follow-ups to ensure effective and timely resolution of complaints and implementation of appropriate control measures, as recommended.
Conducts ongoing review of existing patient and public safety policies, procedures, standards and credentialing activities and other related standard operating procedures to identify barriers to success, gaps or discrepancies and recommends workable and cost-effective solutions or revisions, in consultation with appropriate staff.
Compiles, reviews and interprets risk, regulatory and compliance data, and presents key findings to various committees and other stakeholders and creates strategies and recommendations for interventions and appropriate control measures.
Ensures new regulations are disseminated throughout the health care setting and are implemented in appropriate departments. Partners with senior leadership to develop and maintain alert monitoring and reporting procedures and to create strategies and action plans to address potential regulatory concerns, reduce the likelihood of noncompliance and lessen the impact of related risks if/when they occur.
Assists in the development of training programs and provides orientation, training, and guidance to staff. Routinely assesses staff learning needs identifying gaps and evaluating the quality and effectiveness of the training programs. Implements necessary changes in training and development to maximize productivity, effectiveness and efficiency of staff.
Investigates incidents involving noncompliance with guidelines/procedures, and promptly reports to appropriate local, state and federal public health and regulatory agencies. Analyzes and documents accidents and incidents, utilizing appropriate tools and other applicable methods of analysis, to identify contributing factors and other safety concerns.
Prepares and/or actively participates in the development of the fiscal year expense, revenue and operating budgets. Ensures operations run within budgetary guidelines, reviews budget requests for regulatory services and monitors all regulatory-related expenses and purchases.
Coordinates all regulatory and accrediting agency audits and inspections, leading the department’s survey preparation efforts and maintains and continuously assesses regulatory survey readiness and ensures timely submission of corrective actions plans and implementation of corrective actions, when required.
Provides post-survey recommendations for sustainable safety initiatives. Maintains an Environment of Care under accreditation standards by ensuring ongoing maintenance of all required departmental regulatory accreditations.
Ensures ongoing compliance and maintenance of the NYC Health + Hospitals policies and procedures with national standards and other applicable external regulatory requirements, guidelines and accreditation authorities, as well as safety and quality management standards.
Participates in internal/external quality assurance/performance improvement (QA/PI) activities, programs, and training, as required.
Qualifications Juris Doctor degree from an accredited school of law, admission to the New York State Bar (NYS Bar), AND five (5) years of responsible experience in the practice of law following NYS Bar admission, in the fields of health care compliance, regulatory affairs, risk and quality management and/or in similar areas;
OR Master’s degree from an accredited college or university in Health Administration, Hospital Administration, Public Health, Business Administration or in a related health care specialization, AND five (5) years of experience in compliance and regulatory affairs, risk and quality management, credentialing, leading and implementing performance improvement and process management programs and strategies, and performing other functions related to regulatory management in a hospital or a health care setting, three (3) years of which must have been in a responsible administrative, managerial or supervisory capacity;
OR Bachelor’s degree from an accredited college or university in fields, as described above; and seven (7) years of health care-related regulatory management experience, as described above, five (5) years of which must have been in a responsible administrative, managerial or supervisory capacity;
RN License or previous clinical experience preferred
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Responsibilities
Serves as a proactive change agent promoting regulatory readiness, and assists in the integration of standards and requirements into the department. Ensures the delivery of patient-centered, cost-effective, quality services across the continuum of care, optimal utilization of resources and ongoing compliance with applicable local, state, federal rules, regulations and security standards.
Provides strategic regulatory leadership and leads the day-to-day operations of the department and regulatory and compliance programs, following guidelines and regulatory requirements and monitors the overall effectiveness of the program and departmental activities.
Partners with senior leadership and other key stakeholders to define the strategic direction and operational plan for advancing regulatory and compliance programs, ensuring alignment with the System’s mission, values, and business goals.
Develops and implements quality assurance initiatives and related services to ensure compliance with regulatory mandates, and establishes program and service goals and priorities.
Investigates and reviews regulatory complaints and other related issues and coordinates correction and/or resolution, conducting follow-ups to ensure effective and timely resolution of complaints and implementation of appropriate control measures, as recommended.
Conducts ongoing review of existing patient and public safety policies, procedures, standards and credentialing activities and other related standard operating procedures to identify barriers to success, gaps or discrepancies and recommends workable and cost-effective solutions or revisions, in consultation with appropriate staff.
Compiles, reviews and interprets risk, regulatory and compliance data, and presents key findings to various committees and other stakeholders and creates strategies and recommendations for interventions and appropriate control measures.
Ensures new regulations are disseminated throughout the health care setting and are implemented in appropriate departments. Partners with senior leadership to develop and maintain alert monitoring and reporting procedures and to create strategies and action plans to address potential regulatory concerns, reduce the likelihood of noncompliance and lessen the impact of related risks if/when they occur.
Assists in the development of training programs and provides orientation, training, and guidance to staff. Routinely assesses staff learning needs identifying gaps and evaluating the quality and effectiveness of the training programs. Implements necessary changes in training and development to maximize productivity, effectiveness and efficiency of staff.
Investigates incidents involving noncompliance with guidelines/procedures, and promptly reports to appropriate local, state and federal public health and regulatory agencies. Analyzes and documents accidents and incidents, utilizing appropriate tools and other applicable methods of analysis, to identify contributing factors and other safety concerns.
Prepares and/or actively participates in the development of the fiscal year expense, revenue and operating budgets. Ensures operations run within budgetary guidelines, reviews budget requests for regulatory services and monitors all regulatory-related expenses and purchases.
Coordinates all regulatory and accrediting agency audits and inspections, leading the department’s survey preparation efforts and maintains and continuously assesses regulatory survey readiness and ensures timely submission of corrective actions plans and implementation of corrective actions, when required.
Provides post-survey recommendations for sustainable safety initiatives. Maintains an Environment of Care under accreditation standards by ensuring ongoing maintenance of all required departmental regulatory accreditations.
Ensures ongoing compliance and maintenance of the NYC Health + Hospitals policies and procedures with national standards and other applicable external regulatory requirements, guidelines and accreditation authorities, as well as safety and quality management standards.
Participates in internal/external quality assurance/performance improvement (QA/PI) activities, programs, and training, as required.
Qualifications Juris Doctor degree from an accredited school of law, admission to the New York State Bar (NYS Bar), AND five (5) years of responsible experience in the practice of law following NYS Bar admission, in the fields of health care compliance, regulatory affairs, risk and quality management and/or in similar areas;
OR Master’s degree from an accredited college or university in Health Administration, Hospital Administration, Public Health, Business Administration or in a related health care specialization, AND five (5) years of experience in compliance and regulatory affairs, risk and quality management, credentialing, leading and implementing performance improvement and process management programs and strategies, and performing other functions related to regulatory management in a hospital or a health care setting, three (3) years of which must have been in a responsible administrative, managerial or supervisory capacity;
OR Bachelor’s degree from an accredited college or university in fields, as described above; and seven (7) years of health care-related regulatory management experience, as described above, five (5) years of which must have been in a responsible administrative, managerial or supervisory capacity;
RN License or previous clinical experience preferred
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