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Paris Area, France France

Regulatory Affairs Director in Hexacath - Novacor

Medical / Health Care / Pharmaceuticals

My main experience is in the field of Medical Devices: - Expertise in European regulation (Medical Devices Directive 93/42/EEC), - Knowledge of other regulations: Canada, USA, Australia / New Zealand, Taiwan, India, Brazil, China - Technical files for CE mark of class III and II medical devices - Preparation, management and review of international regulatory submissions for marketing clearances in domestic and international regulatory agencies - Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry - Control of product documentation and promotional material in compliance with the regulations - Control of the appl...