Althen-des-Paluds, Provence-Alpes-Côte d'Azur, France
In charge of regulatory affairs and responsible of multiple projects related to clinical research and clinical evaluation
Mission : to develop an innovative bioreactor for corneal graft preservation Management of a comparative study : grafts conservation in bioreator and in organ-cultur Mechanical engineering (Solidworks, 3D printing) Communication at the EVER (European Association for Vision and Eye Research) congress Project management, R&D documentation, supplier relationship Autonomous, Hard-working, Multidisciplinary skills
Mission : to develop an innovative system of assistance for the prevention of surgical site infections Project management, R&D documentation, Opinion Leader and supplier relationship Risks management Regulatory and market access strategy Quality Management System construction according to the standard NF EN ISO 13485 : 2012 Draft of a test protocol according to the standard NF EN ISO 16698-1 : 2004 Versatility, Hard working, Organizational and relational skills
Mission : to create and update the Design History Files of the products which were not designed according to the Corporate Product Design/Global Innovation Process (CPD/GIP) V&V organization and formalization Design History File updating and establishment To report on the progress of the project to the Head of Product Development Dental R&D documentation in compliance with regulatory requirements Autonomous, rigorous, dynamique, analytical mind