Job Details
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Job Description
Main Job Tasks & Responsibilities:
- Acting as front office for all documents submitted to CAPA or NODCAR.
- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners.
- Advise on the submission strategy Timely compile materials for license renewals, updates and registrations Maintain regulatory files/database and chronologies in good order.
- Establish and maintain system for tracking changes in documents submitted to agencies or partners
- Responsible for all steps of Research issues.
- Responsible for getting Release permeation for any Shipment from CAPA.
- Responsible for following the Analysis Certificates from NODCAR.
Job Requirements
Education & Experience:
- Medical background degree or equivalent professional qualification
- At least 1-3 years relevant experience within the regulatory affairs discipline
- CTD and Export Experience are a Must
- Knowledge of Egyptian and International Medical Device Regulatory requirements
- Relevant product and industry knowledge
