asmaa mostafa yakout

International communication with mother companies for medical device
Registration.
 Build up and maintain regulatory department database
 Follow up medical registration in SFDA for Medical Equipment.
 Approve all shipment documents to avoid any problem in clearance procedure
 Review all Pre-Forma invoices from suppliers upon our purchase orders and
Follow up all shipments.
 Renewing MDEL (medical device establishment license) and follow up required
Documents 2 months before.
 Preparing the SFDA A.R (Authorized Representative) Agreement.
 Registering the manufacturers, we have as Authorize Representative in SFDA
(MDEL System).
 Preparing the requests for import license in SFDA (MDIL System - Medical
Device Importing License).
 Preparing report for all SFDA license to renew on time to avoid any problem in
importing and distributing.
 Following up the Recall from (NCMDR System - National Center for Medical
Devices Reporting) and Close recalls and FSN.
 Preparing the requests for classification in (MDC System - Medical Device
Classification)
 Having approval on social media marketing license from SFDA.
 Prepare documentation of SGH file.
 Obtaining medical device ware house license
 Inspecting situation of items with Saudi customs under which procedure.
 SABER Registration.
 Submitting clearance requests for medical devices through ghad system.
Building Quality system for obtaining ISO 13485.

Working as regulatory affairs specialist from 2015 till
15/9/2023 Al-Hammad medical company.
Work as medical representative from 2013 until 2015.
Work from 2010 until 1/12/2012 as quality auditor on Elsayed group in Egypt.
Work from 2008 until the end of 2010 as exporter and importer specialist.
Work from 2007utill 2008 as executive secretary.