Conformity Analyst (Regulatory) – Medical Devices & Supplements at SGS

Jebel Ali, Dubai, United Arab Emirates -

Full Time

Start Date

Immediate

Expiry Date

24 Sep, 26

Salary

0.0

Posted On

26 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Submissions, Dossier Preparation, EU MDR, Product Classification, Labeling Compliance, Gap Assessment, ISO 13485, Stakeholder Management, Technical Documentation, Conformity Assessment

Industry

Professional Services

Description

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. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance, and sustainability. 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. Additional Information

Responsibilities

Manage end-to-end regulatory submissions for medical devices and supplements across the Middle East, including coordination with authorities like MoHAP and SFDA. Prepare technical dossiers aligned with EU MDR and regional requirements while monitoring regulatory updates.