1. Registration and Re-registration of IVDs:Oversee the entire process of registering and re-registering In Vitro Diagnostic (IVD) devices.Ensure compliance with regulatory requirements, including submission of required documentation for the Importation approvals( regular / annual ) of IVDs 2. Monitoring Certificate Validity:Regularly check the validity of certificates associated with IVDs, including expiration dates.Coordinate with direct managers to follow up on the status of certificates and contracts to ensure there are no gaps in compliance.3. Document Management & Expiry Tracking:Keep track of the expiration status of all relevant documentation and certificates.Proactively follow up with management to prevent delays or lapses in documentation renewal.4. EDA Liaison:Serve as the primary point of contact with the EDA (Egyptian Drug Authority). Medical Device Registration File Preparation:Prepare comprehensive registration files for medical devices (including IVDs), ensuring all required documentation is complete and compliant with regulatory guidelines.Submit applications to the relevant regulatory authorities for approval.6. Importation Approvals & Plans:Manage the preparation of importation approvals and plans for both registered and under-registration products, in alignment with sales forecasts.Ensure that all importation processes adhere to regulatory guidelines and deadlines.7. Pharmacovigilance:Oversee pharmacovigilance procedures, ensuring proper tracking, reporting, and handling of adverse events related to medical devices and IVDs.Manage the submission process for pharmacovigilance approval, ensuring compliance with regulations.8. Coordination of Inspections:Coordinate with the EDA inspectors to schedule and facilitate inspections of medical device facilities and products.Ensure that all necessary preparations are made to ensure smooth inspection processes and compliance with regulatory requirements.

responsible for meeting with doctors and pharmacists at a timely mannerand deliver orders to the company

On ground Medical representative for Antopral 20 and Diclac gel in El Maadi