Regulatory Affairs Specialist – Medical Devices

Company: EGMED –

WebSite: Cairo, Egypt

Job Description:The incumbent is responsible for managing all aspects of regulatory affairs, including but not limited to: preparing and maintaining registration files compliant with MOH regulations, encompassing contracts, S14 certification, Conformity European for QA (CE), Free Sales Certificates (FSC), and Food and Drug Administration (FDA) documentation; proactively planning and executing new product registration procedures; securing timely regulatory approvals and renewals through consistent engagement with MOH personnel; serving as the primary point of contact for MOH representatives and suppliers; maintaining accurate and up-to-date registration licenses, communicating effectively with the MOH Administration; collaborating with MOH Inspectors, supply chain, and warehouse teams to expedite product release, providing all necessary documentation; coordinating with NODCAR, NORCB, Nutrition Institute, and MOH central Lab to ensure prompt analysis of withdrawn samples; monitoring and reporting documentation validity to management, alerting them to impending expirations; ensuring regulatory compliance of approved products regarding pricing, shelf life, packaging, manufacturing sites, and codes; managing warehouse and factory licensing processes with the MOH; preparing and submitting annual pharmaceutical product import plans; facilitating communication between the company and MOH authorities through meetings and direct contact with relevant MOH personnel; confirming registration status with the Order Processing Department to prevent customs clearance delays; acting as a liaison between the customs department and various Business Units for document flow; providing monthly registration status reports and addressing any potential issues to management; performing general administrative tasks, including file maintenance and paperwork processing; preparing and monitoring import file submissions to the MOH; and serving as the Deputy Pharmacovigilance Responsible Person (PVRP).

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