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Regulatory Affairs Executive
2 weeks ago
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. Qualifications 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. #J-18808-Ljbffr
