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.
This position is responsible for the day-to-day operations and oversight of the quality improvement department staff to ensure all regulatory and quality related activities are performed with efficiency and accuracy. This position requires exceptional interpersonal communication, customer service, and organizational skills required. The quality improvement supervisor is required to meet all managed care delegation requirement for this position to ensure compliance with meeting all turnaround times for preservice appeals, grievances, health plan audits and denial letters.
Manages day to day oversight of staff activities to ensure consistent processes are identified and implemented to achieve compliance in accordance with health plan delegation agreements and with appeals and grievances, potential quality of care concerns, Prepares and maintains QI Appeals and Grievances reporting, Access Audits.
Identify any training opportunities and develop and maintain training templates, forms, reports, and other tools that will assist the staff in meeting the needs of the department and organization. Facilitates training/cross training of staff in processes to maximize effectiveness and to utilize staff to their fullest potential
In collaboration with the department manager; reviews, revises, and develops policies and procedures for the department, annual QI work plan, department structure and annual goals