Regulatory Affairs Specialist

STARK -
Maadi, Cairo

STARK -
Maadi, CairoPosted 2 months ago

63Applicants for1 open position

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Prepare and submit shipment files to EDA and relevant authorities (MOH, GOEIC, etc.).
Ensure that all required documents (invoices, certificates, permits) are complete and compliant with Egyptian regulations.
Ensure the company’s compliance with all regulations set by EDA, MOH, GOEIC, and other relevant authorities.
Follow up on shipment approvals and address any issues or delays to ensure timely clearance.
Prepare and submit product registration files with the EDA, including supplier communication and coordination with EDA supervisors.
Manage the registration of new agency/distributor contracts and issue the agency card.
Maintain and update supplier documents, ensuring all required certificates and regulatory documents are up to date.
Manage GS1 product compliance (barcode registration, updates, and tracking).
Coordinate with internal teams (logistics, finance, and legal) to ensure smooth operations and compliance.

Bachelor's degree in Pharmacy, Science, Business, or a related field.
Minimum of 2 years of experience in regulatory affairs, shipment approvals, or medical device registration.
Very good command of English (both written and spoken) – required for handling supplier communication and official documentation.
Strong understanding of EDA, MOH, and import regulations.
Experience working with medical equipment ( class I& II )is preferred.
Proficiency in Microsoft Office (Excel, Word, Outlook).
Strong organizational and follow-up skills.
Ability to handle regulatory paperwork and liaise with government agencies efficiently.