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Regulatory Affairs Specialist

Sky Medical for Medical Devices
Mohandessin, Giza
Posted 3 years ago
87Applicants for1 open position
  • 56Viewed
  • 10In Consideration
  • 5Not Selected
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Job Details

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Job Description

  • Responsible for preparation of Registration dossiers of all new products and Re-registered products.
  • Submitting variations of existing products.
  • Responsible for preparation and submission of Analytical dossiers to NODCAR ( National Organization for Drug Control and Research ).
  • Follow up submission and any supporting documents along with registration lead time.
  • Support logistic team with all references, legalized certificates and material needed for regular analysis and release.
  • Prepare analytical files to be submitted to different authorized labs
  • Follow up analysis and supply all needed requirements to get release certificates f samples.
  • Ensures confidentiality in respect of registration files contents.
  • Completing all registration requirements for all shipments at EDA.
  • Responsible for obtaining Ministry of Health importation approvals, inspection & release.

Job Requirements

  • Bachelor’s degree in Science, pharmacy or vet medicine.
  • Knowledge of EDA regulatory affairs is a must.
  • Experience mainly in sterile medical devices regulatory and submissions in CAPA, NODCAR.
  • Good knowledge of preparation of registration files.
  • Excellent command of English and Arabic
  • 1-3 years of experience.

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