Regulatory Affairs Specialist

The Regulatory Affairs Specialist is responsible for managing the regulatory activities required to register, import, market, and maintain compliance for medical devices in Egypt.

The role ensures that all products meet Egyptian Drug Authority (EDA) requirements, as well as applicable regional and international standards.

Responsibilities: 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 ComplianceSupport auditing processes and regulatory inspections.

Bachelor’s degree in Pharmacy, Biomedical Engineering, Biotechnology, Life Sciences, or related field.· 1–2 years of regulatory affairs experience in the Egyptian medical device industry.· Experience dealing directly with EDA submissions and systems (such as device listing, import license, or registration platforms) is strongly preferred.