Conformity Analyst (Regulatory) – Medical Devices & Supplements

• 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.

Qualifications :

• Bachelors 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 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.

Additional Information :

Remote Work :

No

Employment Type :

Full-time