RAQA Manager
Talents Solutions
- Lyon
- CDI
- Temps-plein
- Establishing and maintaining the quality management system in accordance with MDR (EU) 2017/745, and ISO 14001 environmental management system
- Monitoring regulatory developments, analyzing their impact on activities, and implementing compliance action plans where applicable
- Managing relationships with relevant Health Authorities to:
- Ensure that processes necessary for the quality management system are established, implemented, and maintained
- Reporting to management on the functioning of the quality management system and any need for improvement
- Ensuring awareness of customer requirements throughout the organization
- Implementing safety corrective actions required by Manufacturers or relevant Health Authorities, including batch recall activities and dissemination of warning notices
- Exchanging information with the quality and regulatory functions of the group
- Translating the quality and regulatory requirements of the group into operational tasks
- Ensuring monitoring of external regulatory documents concerning products distributed and transmitted by legal manufacturers of the products
- Participating in the selection, evaluation, and control of suppliers and subcontractors
- Participating in the review of tenders
- Participating in the control of advertising related to marketed medical devices