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.
The incumbent is responsible for ensuring thorough monitoring and auditing, the organization’s adherence to compliance with federal, state and international laws and regulations including the Health Insurance Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR), Federal Antikickback Statute, Stark Law and False Claims Act. Monitoring and auditing compliance programs and evaluating the organization’s risk, regulatory, and controls framework and integrity of billing professional fees.
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