Director of Regulatory Affairs

Lincoln Medical and Mental Health Center is one of New York City’s premier acute care hospitals. Located in Downtown Bronx, Lincoln is a teaching hospital renowned for its Centers of Excellence, and a recognized industry leader in the implementation of state-of-the art medical technology and best practices. Our team of highly trained and caring medical professionals is dedicated to providing the highest quality health care that is safe, compassionate, culturally competent and patient-centered.

Comprehensive services are offered in three major primary care areas: Medicine, Pediatrics, and Women’s Health in addition to more than eighty (80) specialty services. At Lincoln, the safety and comfort of our patients is our number one priority. At NYC Health + Hospitals, our mission is to deliver high quality care health services, without exception.

Every employee takes a person-centered approach that exemplifies the ICARE values (Integrity, Compassion, Accountability, Respect, and Excellence) through empathic communication and partnerships between all persons.

8:00 A.M – 4:00 P.M; Monday to Friday . *[35 Hours per Week.]

PURPOSE OF THE POSITION: Under direction of the Chief Quality Officer of the facility, 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.

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.

DUTIES AND RESPONSIBILITIES

• Regulatory Affairs activities: (1) trains middle managers and senior leaders on how to conduct Tracer, as internal Mock Surveyors, (2) use of AMP Tracer Program, (3) prepares agenda and presentations for the Accreditation & Regulatory Compliance Committee (ARCC) meeting with primary focus on survey readiness, (4) manages all on-site regulatory visits, (5) coordinates all activities surrounding the application and on-site readiness for TJC Disease Specific Certifications, (6) coordinates the formulation of a comprehensive Plan of Correction (POC) with relevant staff/leaders, and (7) ensures the monitoring of POCs and providing compliance feedback to stakeholders.
• 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. Identifies problems affecting the delivery of services and recommends and/or implements standard, cost-effective measures for service improvement.
• 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.
• Conducts research and studies to identify and analyze compliance trends in regulatory affairs and may participate in special studies on quality and in other regulation-related areas. Oversees and/or participates in various committees, assessing and predicting changes in risk and regulation.
• 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.
• Serves as a principal advisor and key resource to senior leadership and other parties, and as liaison between appropriate agencies and departments on all matters pertaining to patient and public health regulations, compliance, quality of care and patient safety and other matters relating to regulatory excellence.
• Participates in Risk Management activities including RCA2 and coordinates monitoring of corrective action as applicable.
• Participates in Various committees not limited to Infection Control, Patient Safety, Environment of Care, Risk Management, and Sepsis to ensure safety and quality of care for all patients.
• Performs other related duties as assigned by the Chief Quality Officer.

1. 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
2. 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
3. Bachelor’s degree from an accredited college or university in fields, as described in “2” above; and seven (7) years of health care-related regulatory management experience, as described in “2” above, five (5) years of which must have been in a responsible administrative, managerial or supervisory capacity; or
4. A satisfactory equivalent of education, training and/or experience.

NYC Health and Hospitals offers a competitive benefits package that includes: Comprehensive Health Benefits for employees hired to work 20+ hrs. per week Retirement Savings and Pension Plans Paid Holidays and Vacation in accordance with employees' Collectively bargained contracts Loan Forgiveness Programs for eligible employees College tuition discounts and professional development opportunities College Savings Program Union Benefits for eligible titles Multiple employee discounts programs Commuter Benefits Programs

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