UAE Medical Device Registration & Regulatory Affairs Lead

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

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.