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.
Overview Primary Objective: This position is responsible for preparing and coordinating regulatory submissions in accordance with Nonin policies and procedures on a world-wide basis. This position works closely with product development teams to develop and provide timely and accurate regulatory requirements, submission strategies and guidance for new products and product modifications. This position works closely with regulatory authorities to assure that Nonin products comply with regulatory requirements and are approved in a timely manner; this position also liaisons with third-party, externa
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