Sid Melbouci

Regulatory Affairs Engineer @Zimmer Biomet Robotics (formerly Medtech SA)

Montpellier, FR

CONTEXT: MAINTENANCE OF MDR & MDD CERTIFICATION AND INTERNATIONAL\\\\nREGISTRATIONS.\\\\nSupported department: R&D, Regulatory Affairs, clinical department, international registration, Supplier quality,\\\\nQMS, Manufacturer site\\\\nKey words: target patient population, performance, RMF, Software, reuse, sterilization, cleaning, and disinfection,\\\\ndevice compatibility, Usability, User interface, US Market, US FDA, change assessment, Notify Body Audit.\\\\nRESPONSIBILITIES:\\\\n-Writing and approve of EC technical documentation for class IIb of Electro-medical device\\\\nincorporating software applications.\\\\n-Update standard checklist (IEC 62366-1, ISO 14971, IEC 62304, IEC 60601)\\\\n-Review and approve the technical documentation related to the products: IFU (user Manuel), BSE.\\\\n-Lead 510k submission as well as the follow-up of US FDA questions\\\\n-Perform Regulatory Monitoring and manage gap assessment.\\\\n-Participate in remediation projects and EUDAMED implementation.\\\\n-Conduct impact analysis of Product changes under MDR certification and perform international change\\\\nnotification.\\\\n-Approval of final product release and orders of products and spare parts.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n

Polytech Lyon

Regulatory Affairs , Medical Device Spescialist, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs, Master 2

Institut de Pharmacie Industrielle de Lyon (IPIL)

Engineering for health and medicine (ISM IPIL), Bioengineering and Biomedical Engineering, Master 1

Abou Bekr Belkaid University of Tlemcen

Biomedical Engineering, Biomedical Electronics, Bachelor