Regulatory Affairs & Importation Executive

Full Job Description

Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.

job Brief Responsible for all Product Classification/Manufacturing Site Registration and Product Registration and to ensure that all documents required are available and are submitted on time. They are also responsible for the preparation of the pre- and final perm

• Adhere to all Zahrawi Policies & Procedures as applicable.

Regulatory Affairs:

• Ensure that Zahrawi’s products comply with the regulations of the MOH.
• 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.

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 MOH.
• Prepare all required documents to be submitted for Manufacturing Site registration under MOH.
• Prepare and apply for the pre-permit document as per the MOH guidelines and verify the items being imported and the documents required.
• Communicate with the existing and new suppliers regarding MOH importation rules and policies.
• Upload on the MOH importation system any new classifications or registration certificates.

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.

Pharmacovigilance System:

• Responsible for Pharmacovigilance related work and assigned as deputy QPPV.
• Report Adverse Drug Reactions (ADRs) for all products by collating the needed information and incorporating customer’s comments.
• Conduct monthly PV activities to keep full compliance with the regulations.
• Prepare and review all SOP’s Pharmacovigilance plans for all Zahrawi Suppliers.

Medical Devices FSN/FSA Vigilance system:

• Report the received FSN/FSA to the health Authority and keep align with the reporting timelines.
• Keep tracking for the reported cases and the health Authority requirements to ensure fulfillment.
• Keep updated with the new regulations related to the local vigilance system and report them to the manager

• Candidates must be based in the UAE and should be willing to move to company visa
• Candidates must have a valid MOH license
• Experience: 2 - 4 years of experience.
• Job Specific Skills: Require a good knowledge in Pharmacist, Regulatory Affairs, Importation Permits

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