oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions. Coordinates inspection of the organization and contract facilities, and develops procedures to ensure?regulatory?compliance.
Accompanying technical documentation for drug, health products, medical devices, revising already existing technical documentations
Communication with responsible regulatory authorities (SFDA) as well as with notified bodies
Examining the conformity (all documents for approval must be compliant to all relevant regulations, rules and standards) and taking part in the conformity assessment procedures with coordination of all concerned departments.
Being the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of products.
