Conformity Analyst (Regulatory) - Medical Devices & Supplements

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Additional Information

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. Bachelor's degree in pharmacy, Biomedical Engineering, Life Sciences, Chemistry, or related field. 2-5 years of experience in regulatory affairs, product registration or conformity assessment for medical devices, supplements or related healthcare products. Working knowledge of EU MDR technical documentation requirements and UAE / GCC registration pathways, including dossier preparation and submission coordination. Adept in ISO 13485 quality management system requirements and their application to medical device regulatory documentation and compliance processes. Strong documentation, analytical, and stakeholder management skills.

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Company Intel

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