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Regulatory Affairs Supervisor

GMS
Bourj Alarab, Alexandria
Posted 4 years ago
21Applicants for1 open position
  • 11Viewed
  • 8In Consideration
  • 0Not Selected
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Job Details

Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:

Skills And Tools:

Job Description

Main duties:

  • Generation/update of registration procedures relevant to regulatory compliance and registration activities based on the regulatory requirements.
  • Collection of data and documents required for registration from the relevant departments.
  • Compilation of registration/re-registration/importation files inside and outside Egypt.
  • Submission and follow-up of registration files with competent authorities inside and outside Egypt in the required timelines.
  • Compliance with applicable regulations and laws required by national and international authorities.
  • Share in review of the technical documentation and the EU declaration of conformity.
  • Share in review of the post-market surveillance execution documents.
  • Share in review of "Vigilance System" reports.
  • Participate in internal audits as per the audit program.
  • Share in risk management, change control and handling of deviations, whenever required.

Job Requirements

Experience:

  • 2 to 3 years' regulatory experience or
  • 4-5 years' Quality Assurance experience
  • Company Industry: Medical Devices & Pharma
  • Location: based Alexandria
  • Education: graduate from faculty of Sciences or Pharmacy.

Skills:

  • Very good computer and language skills.
  • Very good communication/presentation skills.

Abilities:

  • Ability for domestic travel.
  • Ability for accepting new ideas and adapting to new assignments.
  • Problem solving skills.
  • Able to work effectively and efficiently with others

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