Conformity Analyst (Regulatory) – Medical Devices & Supplements
This position is no longer accepting applications(closed Aug 5, 2026).
- 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.