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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.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
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.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
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The Medical Devices Postapproval Bundle links together three critical regulatory compliance activities following completion of the medical device product realization process --post market surveillance; post-release risk management; and corrections, removals and directed recalls. Intended for experienced regulatory, quality systems, medical affairs, legal, compliance management, and product development engineering personnel, this set of courses provide an examination of the applicable regulations, requirements and health authority reporting criteria across each of the three areas for the US, Canada and European Union.
Courses included in this bundle:
Medical Devices: Corrections, Removals and Directed Recalls Examine compliance with US FDA (21 CFR §7, §806 and §810), Health Canada Medical Device Regulations (CMDR) and European Union medical devices directives (MDD, AIMDDand IVDD; and MEDDEV guidance). Definitions of the recall classification and type are explained together with the importance of the recall strategy, planning, communication, reporting and record keeping. 6–12 Hours | 6 RAC credits
Medical Devices: Postmarket Surveillance Review requirements for an effective postmarket surveillance program that satisfies the regulatory and quality system requirements in the US, Canada and Europe. The future of postmarket surveillance programs such as FDA's Postmarket Transformation Initiative and GHTF guidance is addressed. 4–8 Hours | 4 RAC credits
Medical Devices: Risk Management Examine the management of risk as described in ISO 14971:2007, Medical Devices-The application of risk management to medical devicesusing specific examples. Topics addressed include management responsibilities, risk analysis and evaluation, risk controls and lifecycle risk management. 4–8 Hours | 4 RAC credits