Linrco Egypt

Regulatory Affairs Specialist

Linrco Egypt
📍 الجيزة Full-Time 💼 Mid Level (3-5 yrs) 🕐 1h ago
👁️ 0 views
📋 0 applicants

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.

Requirements & Qualifications

  • Bachelor’s degree in Science, pharmacy or vet medicine.
  • Knowledge of EDA regulatory affairs is a must.
  • Hands-on experience in medical devices registration 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.
EGjobank Analysis

Quick Role Summary

Opportunity as "Regulatory Affairs Specialist" at Linrco Egypt located in الجيزة on a Full-Time basis, suited for Mid-Senior Level candidates, within Marketing & Sales. Key details from listing: • Responsible for preparation of Registration dossiers of all new products and Re-registered products. • Submitting variations of existing products. •…

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