RAQA Manager

THE COMPANY:

A world leader in the field of imaging, it has firmly established itself in the industry through its commitment to innovation, quality, and excellence. Across their various divisions, they are committed to capturing, processing, and sharing the world around them, offering cutting-edge solutions that shape the future of imaging technology.

At the heart of their mission is to provide top-notch healthcare solutions. By combining technical expertise, cutting-edge research, and a commitment to continuous improvement, their team is at the forefront of innovation in the development of advanced medical devices that meet the needs of healthcare professionals and patients.

They are driven by a common passion for the positive impact their products can have on people's lives. In their collaborative work environment, they encourage diversity of perspectives and foster a culture where innovation is encouraged and rewarded. Joining their team means being part of a global community dedicated to pushing the boundaries of medical technology for the well-being of all.

THE OPPORTUNITY: 

This position will give you the opportunity to ensure the maintenance of a documented quality management system and to guarantee regulatory compliance for the company.

You will also have the opportunity to ensure effective monitoring of Vigilances and safety corrective actions.

RESPONSIBILITIES:

• 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