Conformity Analyst (Regulatory) – Medical Devices & Supplements
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Key skills for this role
About the Role
SGS seeks a Conformity Analyst to manage regulatory submissions for medical devices and supplements across the Middle East. The role involves preparing dossiers, coordinating with authorities, and ensuring compliance with EU MDR and regional requirements.
Key Skills for This Role
Responsibilities
- Manage end to end regulatory submissions across the Middle East (UAE, KSA, GCC), including application preparation, tracking and authority coordination
- Prepare and review regulatory dossiers and technical documentation aligned with EU MDR and regional authority requirements
- 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
Requirements
- 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
- Adept in ISO 13485 quality management system requirements
- Strong documentation, analytical, and stakeholder management skills
Full Job Posting
Company Description
- SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals.
- We are looking for a Conformity Analyst (Regulatory) – Medical Devices & Supplements in SGS, UAE. The candidate will prepare, review and manage Medical devices and Supplements regulatory.
Job 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 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
- 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.
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