Regulatory Affairs & Quality Assurance Executive

CorDx; Dubai; On-site; AED 180,000 - 260,000; Full time

Job summary

CorDx in Dubai seeks a Pharmacist-in-Charge to manage regulatory affairs for our medical warehouse, maintain the license, and serve as the primary interface with authorities.

The role requires a Bachelor in Pharmacy, DHA licence, bilingual English/Arabic, and proven experience in regulatory submissions, inspections, and documentation. You will ensure compliance for IVD products, recalls, and import permits.

Qualifications

• Bachelor's degree in Pharmacy or equivalent qualification.
• Valid DHA pharmacist licence.
• Eligible for additional licensing to be registered as pharmacist for Dubai operations.
• Regulatory submissions, licence renewals, and inspection prep experience.
• Fluent in English and Arabic for professional correspondence.
• Strong document control and organisational skills.

Responsibilities

• Serve as Pharmacist-in-Charge to maintain license and act as main contact for inspections.
• Oversee receipt, storage, and distribution of IVD products with strict controls.
• Maintain SOPs and manage quarantined, returned, expired, or recalled inventory.
• Prepare, submit, and maintain registrations and dossiers with UAE authorities.
• Coordinate import permits, shipping documentation, and certificates with suppliers.
• Review labels and promotional materials for regulatory compliance; handle complaints and vigilance reporting.
• Track UAE medical device regulations and communicate regulatory impact on operations.

Skills

Regulatory affairs

Bilingual English/Arabic

Document control

Cross-functional communication

Education

Bachelor's degree in Pharmacy

DHA pharmacist licence

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

• 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