About the Role
We are seeking an experienced Regulation & Certification Specialist to manage regulatory compliance, product certifications, and certification renewals across industrial, medical, and consumer product segments. The role involves ensuring compliance with UAE, GCC, and international regulatory requirements, coordinating with regulatory authorities and certification bodies, and maintaining accurate technical documentation.
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Key Responsibilities
- Monitor and ensure compliance with UAE, GCC, and international regulatory requirements.
- Manage product and system certifications, including ISO, FDA, CE marking, and other applicable approvals.
- Prepare and maintain technical files, declarations of conformity, regulatory submissions, and audit documentation.
- Coordinate with certification bodies, notified bodies, third-party auditors, and government authorities.
- Maintain certification and registration records and track renewal deadlines.
- Collaborate with Quality, R&D, Manufacturing, Legal, and Operations teams to ensure regulatory compliance.
- Support internal and external audits and improve compliance processes.
- Monitor regulatory updates, assess compliance risks, and support product lifecycle certification requirements.
Mandatory Requirements
- Bachelor’s degree in engineering, Biomedical Science, Quality Management, or a related field.
- 5–8 years of relevant experience in regulatory affairs, product certification, or regulatory compliance.
- Strong understanding of UAE, GCC, and international regulatory frameworks.
- Hands-on experience managing product certifications, regulatory submissions, technical files, and declarations of conformity.
- Knowledge of ISO 9001, ISO 13485, and relevant quality management and risk management standards.
- Experience coordinating with certification bodies, regulatory authorities, and auditors.
- Strong documentation, project coordination, analytical, and stakeholder management skills.
Preferred Qualifications
- Certification in Regulatory Affairs or Quality Systems.
- Experience in manufacturing, healthcare, medical devices, or industrial sectors.
- Practical exposure to FDA approvals, CE marking, and international product certification processes.
Work Location
Abu Dhabi / Al Ain, UAE, with occasional travel for inspections, audits, or training.
