Join us as QA/RA Director
Join us and take on the challenge of AI in Medical Imaging! Together!
The challenge of Artificial Intelligence applications in medical imaging does not stop when Data Scientists and Software Engineers have delivered software even with the best performances. The software becomes a medical device usable in clinical routine when it complies with proper regulation and quality management system.
To achieve this mission, you will:
• Own regulatory affairs and quality affairs for Incepto.
• Define and manage comprehensive regulatory strategies through all phases of development and product lifecycle.
• Own the overall company performance in meeting the medical device regulation (European MDR)
• Own the overall compliance of the company’s processes and products to any mandatory or elective regulatory / quality requirement set by the organization.
• Share QA/RA expectations with Incepto team members.
• Set up and regularly update the Quality Management System of Incepto
• Monitor Quality KPI’s
• Lead trainings and communication actions in favor of compliancy with applicable Laws, Regulations, Standard and Precedent cases.
• Conduct internal, certification and regulatory audits in collaboration with impacted functions.
• Ensure product registrations in the different market targeted by Incepto
• Manage Post market activities including recalls, field actions, and adverse event reporting
On top of a team of passionate co-workers, you will benefit from:
• Immersion in a clinical site with radiologists
• After-work, restaurants, barbecue, winter/summer meetings, shirts, mugs
• Participate to congress JFR, Vivatech etc…
• Remote work when you need