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...
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