Regulatory Affairs

منذ 3 أيام

Sharjah city, Sharjah, الإمارات العربية المتحدة CorDx دوام كامل

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Serve as the registered Pharmacist-in-Charge to maintain, renew, and update the medical warehouse license, acting as the main contact for authority inspections and inquiriesOversee compliant receipt, storage, and distribution of IVD products, strictly enforcing temperature monitoring, cold-chain controls, expiry tracking, and traceabilityMaintain standard operating procedures for the warehouse and manage the safe handling of quarantined, returned, expired, or recalled inventoryPrepare, submit, and maintain IVD product registrations, variations, renewals, and technical dossiers with the Emirates Drug Establishment and UAE authoritiesCoordinate with manufacturers and supply chain teams to secure necessary import permits, shipping documentation, and certificatesReview product labels and promotional materials for regulatory compliance, while coordinating product complaints, vigilance reporting, and field safety actionsTrack evolving UAE medical device regulations and communicate their impact on operations and product availabilityServe as the registered Pharmacist-in-Charge to maintain, renew, and update the medical warehouse license, acting as the main contact for authority inspections and inquiriesOversee compliant receipt, storage, and distribution of IVD products, strictly enforcing temperature monitoring, cold-chain controls, expiry tracking, and traceabilityMaintain standard operating procedures for the warehouse and manage the safe handling of quarantined, returned, expired, or recalled inventoryPrepare, submit, and maintain IVD product registrations, variations, renewals, and technical dossiers with the Emirates Drug Establishment and UAE authoritiesCoordinate with manufacturers and supply chain teams to secure necessary import permits, shipping documentation, and certificatesReview product labels and promotional materials for regulatory compliance, while coordinating product complaints, vigilance reporting, and field safety actionsTrack evolving UAE medical device regulations and communicate their impact on operations and product availabilityRequirementsBachelor's degree in Pharmacy or an equivalent recognised pharmacy qualificationValid DHA pharmacist licenceEligible to obtain any additional licensing or approval required to be appointed as the registered responsible pharmacist for our Dubai drug store/medical warehouseDemonstrated regulatory affairs experience in Dubai/UAE within medical devices, IVDs, or a related regulated healthcare businessPractical experience with regulatory submissions, licence renewals, authority correspondence, and inspection preparationFluent spoken and written English and Arabic, with the ability to manage professional correspondence in both languagesStrong document-control, organisational, and cross-functional communication skills

Regulatory Affairs

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وظائف مشابهة في Sharjah city

أهم المدن

الأمريكتين

أوروبا

آسيا / أوقيانوسيا

أفريقيا

Regulatory Affairs

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وظائف مشابهة في Sharjah city

أهم المدن