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SGS
SGS
Dubai
2w ago

Conformity Analyst (Regulatory) – Medical Devices & Supplements

DubaiOn-site2–5 yrsFull-time
Responsibilities

Manage end-to-end regulatory submissions for medical devices and supplements across the Middle East, including coordination with authorities like MoHAP and SFDA. Prepare technical dossiers aligned with EU MDR and regional requirements while monitoring regulatory updates.

Requirements

Requires a Bachelor's degree in Pharmacy, Biomedical Engineering, Life Sciences, or Chemistry. Candidates need 2-5 years of experience in regulatory affairs with working knowledge of EU MDR and ISO 13485.

Key skills
Regulatory SubmissionsDossier PreparationEU MDRProduct ClassificationLabeling ComplianceGap AssessmentISO 13485Stakeholder ManagementTechnical DocumentationConformity Assessment
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