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Regulatory Affairs Executive/Specialist
Regulatory Affairs Executive/SpecialistMINDFREE Consulting | Insurance Talent Hub • Riyadh, Riyadh Region, Saudi Arabia
Regulatory Affairs Executive / Specialist

Regulatory Affairs Executive / Specialist

MINDFREE Consulting | Insurance Talent Hub • Riyadh, Riyadh Region, Saudi Arabia
29 days ago
Job description

Accountabilities

Regulatory Affairs

  • Ensure that Zahrawis products comply with the regulations of the SFDA.
  • Keep up to date with the latest changes in regulatory legislation and guidelines.
  • Liaise and negotiate with regulatory authority to ensure a smooth registration process.
  • Provide advice about regulations to customers / suppliers.
  • Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.

Product Classification & Registration

  • Ensure that all required documents and actions for Product Classification / Manufacturing Site Registration and Product Registration are available.
  • Prepare all required documents to be submitted for Product Classification under SFDA.
  • Prepare all required documents to be submitted for Manufacturing Site registration under SFDA.
  • Prepare all the Dossiers to be submitted to SFDA for medical, pharmaceuticals and GSL products.
  • Prepare and submit samples to SFDA for product registration completion.
  • Collect all necessary documents from Supplier to submit for SFDA of products under Ghad System.
  • Register reagents with restricted elements through Ghad System.
  • Importation Permits

  • Prepare and apply for the pre-permit document as per the SFDA guidelines and verify the items being imported and the documents required.
  • Apply for the MOH Narcotics and Pre-cursor Chemical permits on the SFDA website as per the specified guidelines.
  • Register and submit the permits through Ghad system.
  • Resubmit any permits that have not been approved and make sure all the information provided is correct and attach any new documents if required.
  • Prepare weekly / monthly report regarding the rejections / delays for SFDA importation permits and reasons related to that.
  • Check and review the safety data sheet of the restricted element to prepare the required documents for obtaining MOI approval.
  • Exportation Permits

  • Prepare the required documents necessary for obtaining SFDA approval to export medical products outside KSA.
  • Importation Rules & Regulations

  • Communicate with the existing and new suppliers regarding SFDA importation rules and policies.
  • Upload on the SFDA importation system any new classifications or registration certificates.
  • Ensure that all urgent request from the Sales team and suppliers are dealt with in a fast manner and ensure that all documents are in place.
  • Report any deviation from SFDA guidelines of imported shipments and take the corrective and preventive action accordingly.
  • Review on a regular basis the SFDA importation process of distribution agreements.
  • Ensure that the SFDA license is renewed before expiry date to avoid importation disturbance.
  • Segregate the imported products as per HS code in coordination with logistic team and confirm if products are SFDA regulated or not.
  • Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.
  • Audit

  • Prepare any documentation needed for internal and external audits.
  • File all documents in the corresponding files to ensure all are available and are correct.
  • Evaluate the suggestions after the audit and implement them when possible.
  • Admin

  • Assist the Warehouse Coordinators with relevant documents when requested.
  • Coordinate with the Procurement team and assist them with any question they or the Suppliers may have related to SFDA importation.
  • Requirements

  • Education : Bachelors degree.
  • Experience : 2+ years of relevant experience in Regulatory Affairs of Medical Devices
  • Job Specific Skills : Excellent Communication skills (English & Arabic), Good MS. Office skills, Knowledge about Saber System & Ghad System - Knowledge in SFDA regulations.
  • Office Duty : Sunday till Thursday (from 8 : 00 am 5 : 00 pm)
  • #J-18808-Ljbffr

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