Senior Regulatory Scientist, Medical Devices and Combination Products
Voisins Consulting Life Science
Waïss Faissal is working in Voisins Consulting Life Science as Senior Regulatory Scientist, Medical Devices and Combination Products. His responsabilities include the writing, review and preparation of submission of technical file for CE marking or for other markets (USA) in the areas of innovative products, mainly focused on combination products. He is a Doctor of Pharmacy and graduated from the University of Paris Sud where he also completed a Biomedical Engineering Master Degree at the Engineering School of l’Ecole Normale Supérieure des Arts et Métiers (Paris, France).
Among his previous experiences, he worked in GMED North America as a Certification Project Manager and the Drug Usefulness Subject Matter Expert and MDSAP Expert. He managed one of the biggest clients portfolio of the company (including several major accounts) with various certification (ISO 13485:2016, ISO 9001:2015, MDSAP, CE Marking) and in different domains (Directives 93/42/EEC and 98/79/EC and medical devices with an ancillary medicinal substance per Directive 2001/83/EC). Waiss was also deeply involved in the MDSAP and developed as project lead an internal MDSAP training for the Certification Team. In parallel of his activities, he contributed also to the support of the marketing activities: RAPS Convergence (October 2018), Q1 (February 2019), newsletters.
Prior to joining GMED North America, Waïss was working as Regulatory Affairs and Clinical Studies Manager in the Medical Device Industry, for a company specialized in orthopedic implants devices. His responsibilities involved but were not limited to the maintenance and monitoring of Post Market Surveillance (PMS) activities, the Clinical Evaluation and Clinical Investigations data collection and reporting, the evaluation of the new Medical Device Regulation (745/2017) requirements on the company’s activities.
Saturday, September 21
9:00 AM – 5:00 PM
Tuesday, September 24
2:05 PM – 3:00 PM