Regulatory Affairs & Quality Assurance Executive

Company : CorDx

Job Type : Full Time

Dubai, United Arab Emirates

Job Description - Regulatory Affairs & Quality Assurance Executive

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.

Requirements

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.

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Regulatory Affairs & Quality Assurance Executive

Job Description - Regulatory Affairs & Quality Assurance Executive

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