Regulatory Affairs Specialist

Sky Medical for Medical Devices · Giza, Egypt · Posted 2026-04-09

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 labsFollow 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. 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 Arabic1-3 years of experience.

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