Regulatory Affairs

United Imaging Healthcare; Dubai; On-site; AED 335,000 - 558,000; Full time

Job summary

United Imaging Healthcare in Dubai seeks an experienced Regulatory Affairs professional to lead the registration of medical devices in the UAE and GCC. You will develop and execute registration strategies, prepare and submit dossiers to EDE, and manage renewals, variations, and updates.

You will collaborate with internal teams and regulatory authorities to ensure timely approvals and ongoing compliance, including post-market surveillance and reporting.

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 (UAE or GCC preferred).
• Experience in independently managing medical device registration projects in the UAE.
• Strong knowledge of UAE medical device regulations, registration procedures, and EDE requirements.
• Arabic proficiency a plus.

Responsibilities

• Develop and implement medical device registration strategies in the UAE to ensure timely approvals.
• Prepare, review, and submit regulatory dossiers and technical documentation to EDE 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 enable market access.
• Oversee post-market surveillance, adverse event reporting, recalls, and field safety actions.
• Monitor regulatory developments in UAE and GCC; provide guidance to relevant teams.
• Collaborate with Sales, Marketing, R&D, and Quality to support launches and compliance.
• Maintain regulatory records and support audits/inspections.
• Other tasks as assigned by supervisors.

Skills

Regulatory affairs management

Project management

Cross-functional coordination

English fluency

Regulatory intelligence

Education

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

Job description

• 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