Job description

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 required.

Skills

Requirements

• Bachelor’s Degree in Pharmacy, Biomedical Science, Biotechnology, or a related field.
• Minimum 2 years of regulatory affairs experience in IVD or medical device registration in the UAE.
• Proven experience in preparing and submitting product registration dossiers to MOHAP.
• Good understanding of UAE medical device and IVD classification, registration, and importation procedures.
• Familiarity with GCC and international regulatory frameworks (ISO 13485, CE marking, etc.) is an advantage.
• Strong organizational and documentation skills with attention to detail.
• Excellent communication and coordination skills with regulatory authorities.
• Proficiency in English (Arabic is an advantage).
• Based in or willing to relocate to Dubai, UAE.