Conformity Analyst (Regulatory) – Medical Devices & Supplements
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Monthly Salary:
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Job Summary
- 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
About Company
We are SGS the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and ... View more
