Regulatory Affairs Specialist

5 days ago

Cairo, Cairo, Egypt GESCA Full time 40,000 - 60,000 per year

The Regulatory Affairs Specialist will be primarily responsible for managing
importation approvals
for medical devices and consumables — ensuring full compliance with EDA regulations and supporting in registration, vigilance, variation, controlled release, inspection and compliance.

Key Responsibilities:

  • Obtain importation approvals from regulatory bodies
  • Manage medical device registration processes with the Egyptian Drug Authority (EDA)
  • Follow up and maintain regulatory file updates
  • Prepare and arrange vigilance files for medical device safety and compliance

Requirements:

  • Bachelor's degree in Pharmacy or Science or Other
  • 2–5 years of direct experience in importation approvals for medical devices
  • Proficient in both written and spoken Arabic and English
  • Strong organizational and time-management skills; able to work under short deadlines and within a team environment

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