Quality Assurance Regulatory Specialist (REF_0224_QARA)CONTEXTHe/she reports to the Quality Assurance and Regulatory Manager and collaborates to ensure that the devices developed and released to the market meet current regulatory requirements.
Work with RD, QC, manufacturing, and other departments to assure that the products meet Medical Research and IVD Markets.DUTIES AND RESPONSIBILITIESSupport and collaborate with RD to apply the Design Development process to the products.Manage the design change control process.Participate in the process of risk management and support the preparation of risk analysis.Support and collaborate in the DHF preparation.Ensure the correct transfer of product from design phase to production phase, ensuring that production sites have correct specifications, procedures, and work instructions.Prepare and maintain technical files and technical documentation of the products according to the Machinery Directive 2006/42/EC, Regulation 2017/746, and all other applicable laws and standards.Prepare and maintain product documents, such as labeling, instructions for use, and manuals.Draft quality assurance procedures.Implement applicable standards.Manage CAPA (Corrective Action Preventive Action).BASIC REQUIREMENTSDegree in Biology, Chemical, Biomedical Engineering, Electronic Engineering, or equivalent degrees.Excellent English knowledge (written and spoken).2-5 years of experience in Quality Assurance and/or Regulatory Affairs or Research Development or Verification Validation in a company of Medical Devices, preferably In Vitro Medical Devices.Experience with Quality Management System and with ISO 13485, ISO 14971.Ability to lead projects in dynamic environments.Ability to work in a collaborative and multidisciplinary environment, with accuracy, reactivity, reliability, and great attention to detail.Menarini 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.
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