Regulatory Affairs & Quality Assurance Executive
Regulatory Affairs & Quality Assurance Executive
cordxFresher
- Posted 2 hours ago
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Job Description
- 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 inquiries
- Oversee compliant receipt, storage, and distribution of IVD products, strictly enforcing temperature monitoring, cold-chain controls, expiry tracking, and traceability
- Maintain standard operating procedures for the warehouse and manage the safe handling of quarantined, returned, expired, or recalled inventory
- Prepare, submit, and maintain IVD product registrations, variations, renewals, and technical dossiers with the Emirates Drug Establishment and UAE authorities
- Coordinate with manufacturers and supply chain teams to secure necessary import permits, shipping documentation, and certificates
- Review product labels and promotional materials for regulatory compliance, while coordinating product complaints, vigilance reporting, and field safety actions
- Track evolving UAE medical device regulations and communicate their impact on operations and product availability
- Bachelor's degree in Pharmacy or an equivalent recognised pharmacy qualification
- Valid DHA pharmacist licence
- Eligible to obtain any additional licensing or approval required to be appointed as the registered responsible pharmacist for our Dubai drug store/medical warehouse
- Demonstrated regulatory affairs experience in Dubai/UAE within medical devices, IVDs, or a related regulated healthcare business
- Practical experience with regulatory submissions, licence renewals, authority correspondence, and inspection preparation
- Fluent spoken and written English and Arabic, with the ability to manage professional correspondence in both languages
- Strong document-control, organisational, and cross-functional communication skills
More Info
Key Skills
IVD product registrations
Cold-chain controls
Inspection preparation
Expiry tracking
Authority correspondence
Temperature monitoring
About Company