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 provides the opportunity to develop your skill set as an effective regulatory professional in a large medical device division specializing in medical technologies for transfusion and cell therapies. The successful candidate can look forward to professional growth within the organization. Collaborate with international colleagues to generate high quality submission dossiers to obtain medical device approvals in international markets.•Gather design and development information on products from cross-functional teams and submit on-time renewal applications to maintain existing registrations worldwide.•Develop regulatory strategies for countries outside of U.S to ensure speed to market while maintaining high standards of quality.•As
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