Mes compétences :
Linac Technologies
Compliance certification
Medical Imaging
Field service
Medical devices
Team leader
Project Management
CE certification
Compliance
Risk Management
FDA
Entreprises
Varian Medical Systems
- R&D Program Manager
Buc2014 - maintenant
Varian Medical Systems
- R & D Project Manager
Buc2013 - 2014Overall management of R&D projects to release new products or upgrade versions of existing ones
Managing several key projects in parallel and supporting teams in projects achievements
Achieving regulatory clearance for all appropriate markets.
Providing compliance expertise to engineering team to insure safety and compliance to local regulations (China, Brazil, Japan, Canada, USA)
Varian Medical Systems
- Technical Compliance Engineer
Buc2012 - 2013Reporting directly to engineering director. Coaching and expertise for engineering for early inclusion of compliance issues into product development and change management.
Driving compliance to IEC standards of company products, supporting/providing technical files for International Submissions and to Regulatory authorities (FDA, CFDA, CSA, CE)
Supporting factory follow up service, compliance testing (IEC, FDA) and regulatory submissions
Accuray Inc.
- Field Service Engineer (EIMEA)
2006 - 2011
Formations
Biological Research Center, Szeged (Szeged)
Szeged2004 - 2005DESS
Opto-electronic - Recherche et développement d'un microscope laser à balayage. Etude et mise en place d'applications pour ce système afin de permettre l'analyse d'échantillons biologiques
