Responsible & Accountable For :

Responsible for registering of medical devices, veterinary products and food & herbal products with Saudi FDA, responsible in Pharmacovigilance issues and directly coordinating with our suppliers, as well as responsible for any Adverse Events receive from our suppliers to take the necessary action.

Main Tasks :

• Managing of Regulatory Affairs issues whether it is internal and external.

• Responsible for Authorized Representative (AR) agreement/s with Company Suppliers to ensure that it is conforming with SFDA requirements.

• Responsible for Medical Device National Registry (MDNR) listing of medical devices with Saudi FDA.

• Responsible for Medical Device Marketing Authorization (MDMA) of medical devices with Saudi FDA.

• Responsible for classification herbal products with Saudi FDA.

• Responsible for registration of veterinary products with Saudi FDA.

• Responsible for classification of non-medical device with Saudi FDA.

• Responsible for Pharmacovigilance issues with Saudi FDA.

• Responsible for Recall of medical devices / pharmaceutical items, to ensure that it will be complied with SFDA requirements.

• Responsible for Medical Device Import License (MDIL) with Saudi FDA.

• Responsible for clearances of items requested by the governmental hospitals.

• Tasks to represent Company in different governmental offices.

• Tasks to attend meetings with various suppliers (national and international) representing Company.

• Prepare various regulatory submissions for product approval/registration.

• Prepare and submit Saudi FDA applications and respond to Saudi FDA requests for additional information to ensure submission approval.

• Manage Regulatory Affairs employee activities including performance management and recruiting.

• Review governmental rulings to determine changes and probable effects on facility activities.

• Performs other duties and responsibilities as required for smooth and efficient operation.