Regulatory Affairs & Quality Assurance Executive

About the role

The Regulatory Affairs & Quality Assurance Executive will act as the registered Pharmacist‑in‑Charge for CorDx’s medical warehouse in Dubai. The role ensures the warehouse licence is maintained, oversees all regulatory interactions with UAE authorities, and guarantees compliant handling of IVD products.

Key responsibilities

• Maintain, renew and update the medical warehouse licence, serving as the primary contact for authority inspections and inquiries.
• Oversee receipt, storage and distribution of IVD products, enforcing temperature monitoring, cold‑chain controls, expiry tracking and traceability.
• Prepare, submit and maintain IVD product registrations, variations, renewals and technical dossiers with the Emirates Drug Establishment and other UAE authorities.
• Coordinate with manufacturers and supply‑chain teams to obtain import permits, shipping documentation and certificates.
• Review product labels and promotional materials for regulatory compliance and manage product complaints, vigilance reporting and field safety actions.

Required profile

• Bachelor’s degree in Pharmacy or equivalent recognised qualification.
• Valid DHA pharmacist licence and eligibility to obtain any additional licensing required for the role.
• Demonstrated regulatory affairs experience in Dubai/UAE within medical devices, IVDs or related healthcare business.
• Fluent spoken and written English and Arabic.

Required skills

• IVD product registrations
• Cold‑chain controls
• Traceability
• Inspection preparation
• Expiry tracking
• Authority correspondence
• Temperature monitoring
• Regulatory Affairs
• Regulatory Compliance