QARA Associate Apprenticeship Paris

We are looking for an enthusiastic and passionate apprentice to join our QARA (Quality and Regulatory Affairs) team. You will be directly managed by the Head of QARA.Why join AZmed?You will work with developers, data scientists, and doctors on a daily basis. We are going through a fast growth period, so it’s an exciting time to join our team and contribute to AZmed's mission.AZmed’s first product, Rayvolve, an AI-based fracture detection software, has been CE-marked (MDR IIa) for more than two years and recently FDA-cleared.With 700 partners and counting, AZmed has partners in over 30 countries offering the possibility of deploying solutions at scale and used by thousands of physicians around the globe.You will have a complete QARA apprenticeship in the field of Software as a Medical Device that integrates artificial intelligence.ResponsibilitiesIn the QARA team, the apprentice will:Participate in quality assurance activities (e.g., complaint management, NC/CAPA management, post-market survey, software validation, supplier management).Participate in the drafting and review of documents related to regular product modification.Participate in regulatory and standard surveys.Participate in the feasibility, action plan, and implementation of MDSAP requirements.Prepare technical files for submission for international registrations.Participate in the development and maintenance of the company's QMS procedures.QualificationsM1/M2 in Medical Devices.Knowledge of the medical device industry and interest in RAQA.Rigorous and organized.Autonomous.Good communication and collaborative skills.Knowledge of the following standards and regulations is a plus: 2017/745, 13485, ISO 14971, MDSAP, FDA regulation for SaMD, 21CFR Part 820.Include this role’s title in the subject.Include your resumé / LinkedIn … whatever works best for us to get to know you. #J-18808-Ljbffr