Quality Assurance & Regulatory Specialist (Ref_0224_Qa&Ra)

Quality Assurance & Regulatory Specialist (REF_0224_QA&RA)CONTEXT
He/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 RESPONSIBILITIES 
• Support and collaborate with R&D for apply the Design & Development process to the products 
• Managing design change control process 
• Participate in the process of risk management and support the preparation of risk analysis
• Support and collaborate to the DHF preparation 
• Ensure the correct transfer of product from design phase to production phase ensuring that production sites have correct specifications, procedures, work instructions
• Prepare 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 standards 
• Prepare and maintain product's documents, such as labelling, instruction for use, manuals
• Draft quality assurance procedures 
• Implement applicable standards 
• Managing CAPA (Corrective Action Preventive Action) 
BASIC REQUIREMENTS
• Degree in Biology, Chemical, Biomedical Engineering, Electronical 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 company of Medical Devices, preferably In Vitro Medical Devices
• Experienced 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 and reliability and with great attention to details
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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