Regulatory Affairs

Job Responsibilities

Responsible for developing and implementing medical device registration strategies in the UAE, ensuring timely product approvals and compliance with local regulatory requirements;Prepare, review, and submit regulatory dossiers and technical documentation to the Emirates Drug Establishment (EDE) and other relevant regulatory authorities;Manage the entire product registration process, including initial applications, renewals, variations, and regulatory updates;Communicate and coordinate with regulatory authorities, local partners, and internal teams to facilitate product registration and market access;Ensure compliance with post-market surveillance requirements, including adverse event reporting, product recalls, and field safety corrective actions;Monitor regulatory developments in the UAE and GCC markets, assess their impact, and provide regulatory guidance to relevant departments;Collaborate with Sales, Marketing, R&D, and Quality teams to support new product launches and regulatory compliance;Maintain accurate regulatory records and support internal audits and regulatory inspections;Other tasks assigned by supervisors.Qualification Requirements:Bachelor's degree or above in Biomedical Engineering, Medicine, Pharmacy, Life Sciences, or other related fields;Minimum 3–5 years of Regulatory Affairs experience in the medical device industry, preferably in the UAE or GCC region;Proven experience in independently managing medical device registration projects in the UAE;Strong knowledge of UAE medical device regulations, registration procedures, and EDE requirements;Experience in diagnostic imaging equipment or other complex medical devices is preferred;Familiarity with GCC regulatory requirements, particularly Saudi Arabia, is an advantage;Fluent English communication skills; Arabic proficiency is a plus;Strong communication, coordination, and project management skills.Key Competences:Medical device regulatory affairs and complianceUAE medical device registration and approval proceduresRegulatory dossier preparation and submissionPost-market surveillance and regulatory complianceRegulatory intelligence and risk assessmentProject management and cross-functional coordinationCommunication with regulatory authorities and stakeholders