Conformity Analyst (Regulatory) Medical Devices & Supplements
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About the Role
Manage end-to-end regulatory submissions across the Middle East (UAE, KSA, GCC), including application preparation, tracking and authority coordination (e.g., MoHAP, SFDA).
Key Skills for This Role
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Overview
Manage end-to-end regulatory submissions across the Middle East (UAE, KSA, GCC), including application preparation, tracking and authority coordination (e.g., MoHAP, SFDA).
Prepare and review regulatory dossiers and technical documentation aligned with EU MDR and regional authority requirements, ensuring completeness and submission readiness.
Conduct product classification, labeling/claims compliance checks and gap assessments for market entry across UAE and GCC markets.
Liaise with clients, internal teams, and regulatory authorities to support approvals, renewals, and query/deficiency responses.
Monitor regional regulatory updates and maintain submission trackers, documentation, and compliance records.
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