CorDx

Regulatory Affairs Executive

Posted: 12 minutes ago

Job Description

Key Responsibilities:Prepare, compile, and submit product registration dossiers for IVD products to MOHAP and other relevant authoritiesEnsure timely renewal and maintenance of product licenses and regulatory approvalsClassify medical devices and IVD products according to UAE and international regulatory requirementsReview product labeling, packaging, and promotional materials for regulatory complianceLiaise and communicate with MOHAP officers and other health authorities for registration follow-ups and clarificationsMaintain regulatory databases, documentation, and product registration recordsMonitor and interpret changes in regulatory requirements and ensure company complianceCollaborate with internal departments (Quality, Operations, Sales) to ensure all regulatory documentation supports business needsSupport importation and post-market surveillance activities as requiredRequirementsBachelor'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.

Job Application Tips

  • Tailor your resume to highlight relevant experience for this position
  • Write a compelling cover letter that addresses the specific requirements
  • Research the company culture and values before applying
  • Prepare examples of your work that demonstrate your skills
  • Follow up on your application after a reasonable time period

You May Also Be Interested In