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. Esse
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