Import & Export Regulatory Affairs Specialist
FreePL
About the role
We are looking for a detail-oriented Regulatory Affairs Specialist to join our operations team at Swift Egypt. This role is the regulatory backbone of our IOR/EOR operation, every medical device and pharmaceutical import that requires an EDA approval, RUI release, or inspection passes through you.
Key responsibilities
Prepare and submit EDA approvals for medical device and pharmaceutical imports
Manage RUI (Release Under Inspection) file preparation and submission within agreed lead times
Own laser device approval submissions through the relevant authority, separate from EDA
Lead and own EDA physical inspections at the warehouse, preparation, coordination, and attendance
Monitor product registration status and manage annual importation plan submissions
Coordinate with Account Coordinators and logistics teams in real time on all approval statuses
Requirements
→Bachelor's degree in pharmacy, Science, or a related field
→1–2 years of hands-on EDA submission .
→Proven experience handling RUI submissions, EDA inspections, and laser device approvals
→Strong knowledge of Egyptian import regulations, EDA portals.
→Ability to manage multiple open submissions simultaneously under tight lead times
- ...has evolved from a back-office Importer of Record service provider... ...preparing and following up on regulatory submissions, coordinating with... ...years of experience in regulatory affairs, customs documentation, freight forwarding, import/export, or logistics operations. ~...
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