Albara Alkhulaiwi

- Medical Devices & Health products Company which is working on many fields ( Radiology, Laboratory Equipment's (IVF) , Electric Beds, Medical Furniture's and Disposables) .
• Ensure Compliance of regulation set by the relevant authorities in Saudi Arabia that impacts our product portfolio, including but not limited to SFDA, MOI, MOC and Customs.
• Supervise the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
• Supervise and oversee all relevant maintenance activities potentially including Life Cycle Management strategy, and MDMA License maintenance via GTS (Global Tariff System).
• Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications.
• Coordinate successful submissions and approval of all applications.
• Keep up-to-date with changes in regulatory legislation and guidelines.
• Liaise and negotiate with regulatory authorities.
• Supervise document preparation related to regulatory requirements of product import and distribution including but not limited to MDILs.

Budgeting , Sales team coordination and supervision .
Marketing Plans setting .
Conclude deals with Foreign Manufacturers.
Business Development through initiate new distribution channels and get new agencies .

New product(Drug, Health products, Medical Devices) dossier submission and registration at SFDA .
Working with regulatory affair on issues related to SFDA (MDNR, MDIL, AR agreement, MDMA).
Issue import permits (IBRCS, MDIL) .
To coordinate every necessary activities for preparation and evaluation of registrations dossiers and legal documents associated, and to direct and coordinate regulatory activities related to preparation of files for the new products registration processes, modifications, renewals and technical evaluations requirements for registration of products in Saudi FDA where they are needed; asking Global Regulatory support, preparing and sending required documents and giving support to local organizations/Distributors for registration processes, negotiating with authorities any problem related with registrations in process, to obtain the approval for initiate or continue the products commercialization.

Supervision and following up of Drugs Supplies, Medical Supplies and Medical Equipment's in Regional directorates and Head Administrations on Central Headquarter
Coding, EPR Project ( Financing facilitation , Warehouse automation, Logistics ).
Concerned with all aspects relating to tenders of SGH, NUPCO .

Out-Patient pharmacy.
Narcotic Room.
Minor DIC center.
In-Patient .
ER pharmacy .