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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.
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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.
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Strategic Regulatory Solutions, Inc. (SRS) provides Quality Assurance, Regulatory Compliance and Regulatory Affairs consulting services to the medical device design and manufacturing companies of all sizes. SRS specializes in device regulations of the European Community, Canada and USA. Our services include domestic & international product registration strategies and submissions; QMS system installation and enhancement, product development team assistance; internal and supplier audits; regulatory inspection management; product recall management; llitigation support and QMS training. Mr. Kobrin, President and principal consultant, has over 40 years of experience in the Medical Device industry. He is a certified Notified Body and MDSAP lead auditor.
25108 Marguerite Parkway, Suite A-354 Mission Viejo, California 92692 United States Phone: 714-679-6259 Fax: Email: gk@strategicregulatory.com
Gustavo Kobrin President gk@strategicregulatory.com