Regulatory Compliance & Strategy
Ensure full compliance with EDA regulations governing medical device registration, listing, importation, and post-market activities.
Interpret and apply national regulatory requirements, including guidelines and circulars issued by the EDA.
Develop regulatory strategies tailored to Egyptian market timelines and requirements.
Support internal teams by providing clear regulatory guidance for product development, labeling, and market introduction.
Regulatory Submissions (Egypt)
Prepare and submit dossiers for medical device registration to the Egyptian Drug Authority, including required administrative, technical, and quality documentation.
Manage the device classification process based on EDA rules.
Coordinate with EDA officials regarding inquiries, follow-up requests, inspections, or clarifications.
Maintain valid registrations and ensure timely renewals, updates, and import license approvals.
Documentation & Quality Compliance
Support auditing processes and regulatory inspections.