Regulatory Affairs Executive/Specialist

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)