The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Directs the operations of the Quality Department including providing education and training to all staff regarding best practices in the quality arena, providing guidance and support to leadership regarding adherence to regulatory & accreditation requirements, supervises activities to ensure adherence with core measures, collecting, analyzing, and managing data, coordinating communication between committees that drive quality improvements. Maintains up-to-date information regarding all requirements and ensures effective communication of the same. Oversees activities of Quality Coordinator, Core Measures, and Infection Control Practitioners. Ensures completeness and accuracy of submission of required data to appropriate organizations.
Essential Duties and Responsibilities:
Collaborates with members of the leadership team to create and implement quality improvement plans; coordinates Performance Improvement projects hospital-wide; teaches PI concepts and monitors implementation.
Maintains current knowledge base on regulatory/accreditation requirements; monitors and communicates changes.
Conducts mock surveys and provides tools and techniques to improve patient safety and quality of care delivery
Provides recommended methodologies to capture, analyze and report data throughout the organization.
Provides on-going education and training to staff at all levels, including Medical Staff, to improve compliance and quality throughout the organization.
Provides written and verbal communication to external organizations and agencies; oversees and coordinates written and verbal responses to complaints or requests for information
Oversees on-site surveys; Ensures that surveyors receive all requested information; assists with investigations and root cause analyses
Manages a staff of Quality Department to include hiring, assessment, and development of staff
Analyzes data for trends and communicates that information to those responsible for identifying and measuring targeted interventions designed to improve overall performance
College Degree or 5 - 7 Work Equivalent
Clinical background (such as a Registered Nursing license) would enhance qualifications. Candidates may be from a variety of backgrounds.
Must have demonstrated a track record of excellence in data management, reporting, and written/verbal communication.
Humboldt Park Health was recognized as top 10% in the country for patient safety by HealthGrades, awarded Primary Stroke Certification from the Healthcare Facilities Accreditation Program (HFAP) and presented a 2015 Gage Award honorable mention from America’s Essential Hospitals. Other accolades have come from The Joint Commission, Illinois Department of Public Health, College of American Pathologists and American College of Radiology Mammography. These key quality measures are the result of team efforts involving every aspect of our facility.
At Humboldt Park Health, we continually try to make healthcare more effective and responsive to your needs. Our Patient Portals give you easy electronic access to test results, details about your medications, and other information about care received in the hospital and our outpatient clinics. Studies have shown that patients engaged in their own health care have better outcomes.