Location: Castel Maggiore, Bologna, Italy (Hybrid)CONTEXTHe/she report to the Quality Assurance and Regulatory Manager and collaborate in order to ensure that the devices are developed and released on the market meet current regulatory requirements.Work with R&D, QC, manufacturing and other departments in order to assure that the products meet Medical Research and IVD Markets.DUTIES AND RESPONSIBILITIESSupport and collaborate with R&D for apply the Design & Development process to the productsManaging design change control processParticipate in the process of risk management and support the preparation of risk analysisSupport and collaborate to the DHF preparationEnsure the correct transfer of product from design phase to production phase ensuring that production sites have correct specifications, procedures, work instructionsPrepare and maintain technical files / technical documentation of the products according to the Machinery Directive 2006/42/EC, Regulation 2017 /746 and all others applicable laws and standardsPrepare and maintain product's documents, such as labelling, instruction for use, manualsDraft quality assurance proceduresImplement applicable standardsManaging CAPA (Corrective Action Preventive Action)BASIC REQUIREMENTSDegree in Biology, Chemical, Biomedical Engineering, Electronical Engineering or equivalent degreesExcellent English knowledge (written and spoken)2-5 years of experience in Quality Assurance and/or Regulatory Affairs or Research & Development or Verification & Validation in company of Medical Devices, preferably In Vitro Medical DevicesExperienced with Quality Management System and with ISO 13485, ISO 14971Ability to lead projects in dynamic environmentsAbility to work in a collaborative and multidisciplinary environment, with accuracy, reactivity and reliability and with great attention to detailsMenarini Silicon Biosystems S.P.A. is committed to equal opportunity in the terms and conditions of employment for job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity or gender expression, national origin.#J-18808-Ljbffr