Regulatory Affairs & Quality Assurance Executive
CorDx · Dubai, United Arab Emirates · 17d ago
Mid levelOn-siteRisk & Compliance
- 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.