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Regulatory Affairs Specialist

Cairo, Egypt
Posted 5 years ago
115Applicants for1 open position
  • 17Viewed
  • 5In Consideration
  • 0Not Selected
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Job Details

Experience Needed:
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Job Description

Main Job Tasks and Responsibilities:

  • Acting as front office for all documents submitted to CAPA or NODCAR.
  • Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners.
  • Advise on the submission strategy Timely compile materials for license renewals, updates and registrations Maintain regulatory files/database and chronologies in good order.
  • Establish and maintain system for tracking changes in documents submitted to agencies or partners
  • Responsible for all steps of Research issues.
  • Responsible for getting Release permeation for any Shipment from CAPA.
  • Responsible for following the Analysis Certificates from NODCAR.

Job Requirements

Education and Experience:

  • Medical background degree or equivalent professional qualification
  • At least 2-3 years relevant experience within the regulatory affairs discipline
  • CTD and Export Experience are a Must
  • Knowledge of Egyptian and International Medical Device Regulatory requirements
  • Relevant product and industry knowledge


Key Competencies:

  • Excellent written and verbal communication skills organization and planning
  • Problem analysis and problem-solving
  • Persuasiveness, adaptability, judgment, decision-making tolerance & collaboration

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