✨ AI Summary
The Regulatory Affairs Specialist is responsible for preparing and submitting registration dossiers for new and re-registered products, as well as variations for existing products. This role involves preparing and submitting analytical dossiers to NODCAR, following up on submissions and supporting documents, and providing necessary references and legalized certificates to the logistics team. The specialist will also prepare analytical files for authorized labs, follow up on analysis, and obtain release certificates. Key responsibilities include ensuring confidentiality of registration files, completing registration requirements for shipments at EDA, and obtaining Ministry of Health importation approvals, inspections, and releases. A Bachelor's degree in Science, Pharmacy, or Vet Medicine is required, along with a strong knowledge of EDA regulatory affairs and hands-on experience in medical device registration, particularly in sterile medical devices regulatory and submissions within CAPA and NODCAR. Proficiency in preparing registration files, along with excellent command of English and Arabic, and 1-3 years of experience are essential.
Requirements
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 mustExperience 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.
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 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.