Quality Assurance - Regulatory Affairs Junior

Job Opportunity in Rome, Italy An innovative company specializing in in vitro diagnostic devices is seeking a dynamic graduate to join as a Regulatory Affairs, Quality, and Safety Specialist . Only residents of Rome, Guidonia Montecelio, or nearby areas are considered. The successful candidate will be responsible for: Implementing certification projects and maintaining ISO 9001 and ISO 13485 standards, including management review, complaint handling, non-conformities, corrective and preventive actions, conducting audits with notified bodies, and qualifying critical suppliers. Drafting, updating, and distributing quality management system procedures in accordance with UNI EN ISO 9001, 13485, and IVDR 746/2017. Managing and preparing documentation to ensure products meet legal requirements and are properly registered with relevant authorities. Maintaining up-to-date knowledge of applicable regulations and technical files. Developing and updating occupational health and safety documentation. Possessing good command of the English language. Demonstrating strong interpersonal, organizational, and precision skills. Having a good knowledge of Microsoft Office Suite. Performing analysis of reagent compliance, Certificates of Analysis, and quality control on clinical chemistry analyzers. Work location: Industrial Zone, Guidonia Montecelio J-18808-Ljbffr

Location: provincia-di-roma, IT

Posted Date: 6/16/2025