UAE Medical Device Regulatory Lead

United Imaging Healthcare; Dubai; Vor Ort; AED 180.000 - 300.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory affairs

Project management

Dossier preparation

Regulatory intelligence

Communication skills

Ausbildung

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

Jobbeschreibung

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.