Regulatory Affairs Executive

Key Responsibilities

• Prepare, compile, and submit product registration dossiers for IVD products to MOHAP and other relevant authorities.
• Ensure timely renewal and maintenance of product licenses and regulatory approvals.
• Classify medical devices and IVD products according to UAE and international regulatory requirements.
• Review product labeling, packaging, and promotional materials for regulatory compliance.
• Liaise and communicate with MOHAP officers and other health authorities for registration follow-ups and clarifications.
• Maintain regulatory databases, documentation, and product registration records.
• Monitor and interpret changes in regulatory requirements and ensure company compliance.
• Collaborate with internal departments (Quality, Operations, Sales) to ensure all regulatory documentation supports business needs.
• Support importation and post-market surveillance activities as req...