Regulatory Affairs

United Imaging Healthcare; Dubai; On-site; AED 180,000 - 300,000; Full time

Job summary

United Imaging Healthcare in Dubai is seeking a Regulatory Affairs professional to develop and implement medical device registration strategies in the UAE, ensuring timely approvals and compliance with local requirements.

The role involves preparing and submitting dossiers to EDE and other authorities, managing the full registration cycle, and coordinating with sales, QA, and regulatory teams to support market access and post-market surveillance.

Qualifications

• Bachelor's degree or above in Biomedical Engineering, Medicine, Pharmacy, Life Sciences, or related fields.
• 3–5 years of Regulatory Affairs experience in the medical device industry.
• Experience managing medical device registrations in the UAE.
• Strong knowledge of UAE medical device regulations and EDE requirements.
• Experience with diagnostic imaging equipment or complex devices preferred.
• Arabic proficiency is a plus; fluent English required.

Responsibilities

• Develop and implement medical device registration strategies in the UAE to ensure timely product approvals and compliance.
• Prepare, review, and submit regulatory dossiers and technical documentation to the Emirates Drug Establishment and other authorities.
• Manage the full product registration process, including applications, renewals, variations, and updates.
• Coordinate with regulatory authorities, local partners, and internal teams to facilitate registration and market access.
• Ensure post-market surveillance compliance, including adverse event reporting, recalls, and field safety actions.
• Monitor UAE and GCC regulatory developments and provide guidance to relevant departments.
• Collaborate with Sales, Marketing, R&D, and Quality to support launches and compliance.
• Maintain regulatory records and assist in audits and inspections.
• Perform other tasks as assigned by supervisors.

Skills

Regulatory affairs

Project management

Dossier preparation

Regulatory intelligence

Communication skills

Education

Bachelor's degree or above in Biomedical Engineering, Medicine, Pharmacy, Life Sciences

Job description

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 compliance


• UAE medical device registration and approval procedures


• Regulatory dossier preparation and submission


• Post-market surveillance and regulatory compliance


• Regulatory intelligence and risk assessment


• Project management and cross-functional coordination


• Communication with regulatory authorities and stakeholders