They are also responsible for making sure that all our products are classified and registered as per SFDA guidelines.

ACCOUNTABILITIES

Policies & Procedures:

• Adhere to all Zahrawi Policies & Procedures as applicable.

Team Management:

• Ensure that team members meet the performance goals assigned to them.
• Collect periodic reports from team.
•  Delegate short-term targets for the team members.
• Establish regulatory priorities and allocate resources and workloads.
• Train team members on regulatory policies or procedures.
• Help the team members solve task related problems.
• Motivate the team members and making sure that they are following the policies and procedures.

Pharmacovigilance:

• Follow the Pharmacovigilance guidelines of SFDA and prepare all SOPs, product safety reviews and literature reviews when needed.
• Maintain a high level of standard to ensure that all work is moving smoothly and that there are no delays.
• Prepare and review all SOP’s Pharmacovigilance plans for all Zahrawi Suppliers.
• Prepare all Registration and Pharmacovigilance forms and communicate the same to the Suppliers and stakeholders as per SFDA guidelines.

Recall and Field Action Reports:

• Report any spontaneous Individual Adverse Event to the Supplier and the Health Authority. 
• Maintain a soft and hard copy of all Adverse Event for the future. 
• Track and follow up with all active Recall, Field Action and Adverse Event reconciliation with the respective Division Managers and Suppliers and maintain a record. 
• Report all Suspected and Unexpected Serious Adverse Reactions to relevant Health Authorities.

Regulatory Affairs:

• Ensure that Zahrawi’s 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.

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 Registration 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 and IVD products.
• Collect all necessary documents from Supplier to submit for SFDA of products under 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.
• Prepare and submit the required documents to obtain the import permits for restricted elements from SFDA & MOI.
• Apply 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.   

Exportation Permits:

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

Note: Zahrawi employees must step into other work assigned to them as business needs arise and are not limited to the above.

REQUIREMENTS

• Education: Bachelor’s degree
• Experience:  5+ years of relevant experience in regulatory affairs (for medical devices in KSA)
• Job Specific Skills: Effective Communication skills & Good English - Time management skills - Problem Solving Skills - Good computer skills in Ms. Office (Excel– ERP/Oracle system) – Process Management skills – Detail Oriented - Ability to work under pressure – Knowledge about Saber System & Ghad System - Knowledge in SFDA regulations - Leadership skills. 
• Additional Details: Candidate should be Saudi National and based in Riyadh, KSA.