René Becker

Dr. Becker brings in more than 15 years of industry experience mainly in the life science industry. His experience is based on professional experience with large multinational companies, small and medium sized company and start-ups. Specialties are regulatory affairs for medical devices and combination products, quality management systems and process and system validation.

As Head of Regulatory Affairs and Quality Assurance for several Medtech companies he is experienced in developing, implementing and maintaining process oriented Quality Systems meeting the requirements of the European and FDA regulations, in particular ISO 13485, involving tailored Document Management System (fully electronic, hybrid or paper based) incorporating electronic signatures to insure compliance to FDA Quality System Regulations and CFR 21 Part 11 and GAMP guidelines. He is actively involved in the standardization processes of the relevant industrial standards (ISO, IEC, GAMP, etc.) and the evolution of regulation for the medical device and pharmaceutical industry.