Vacancy Description
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 client 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.
Qualifications- Bachelor's degree in pharmacy, biomedical engineering, life sciences, chemistry or related field.
- 25 years of experience in regulatory affairs, product registration or conformity assessment for medical devices, su...
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