Regulatory Affairs - Dubai, United Arab Emirates - Zahrawi Medical

Zahrawi Medical
Zahrawi Medical
Verified Company
Dubai, United Arab Emirates

2 weeks ago

Ahmed Al-Mansouri

Posted by:

Ahmed Al-Mansouri

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Description

About Zahrawi Group:


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
Policies & Procedures:

  • 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.

Importation Permits:


  • 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

REQUIREMENTS
-
Education: Bachelors Degree

-
Additional details:

-
Experience: - 4 years of experience.
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Job Specific Skills: Require a good knowledge in Pharmacist, Regulatory Affairs, Importation Permits


Location:
UAE - Dubai


Job Type:

FULLTIME

Job Posting Date:

Division/Department:
Warehouse Operation and Distribution
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