Regulatory Affairs Manager
Current- Preparation and maintenance of the products’ Technical Files for the CE marking.- Collection of the documentation and preparation of the product dossiers for the international registration (USA, Latin America, Canada, Middle East, China…). - Member of the risk management team. - Preparation and maintenance of the clinical evaluation document.- Responsible for qualification and requalification of the EtO sterilization process.- Post-market surveillance (decision for reporting of events to Competent Authorities)- Backup to Quality Assurance Manager