Regulation and Certification Specialist

About the role

The Regulation and Certification Specialist will ensure that all company products and operations meet local and international regulatory requirements across industrial, medical, and consumer markets. This role acts as the primary liaison with regulatory authorities and certification bodies to secure timely approvals and maintain compliance.

Key responsibilities

• Monitor, interpret, and apply UAE, GCC and international regulatory requirements.
• Maintain up‑to‑date knowledge of changes in laws, standards and certification schemes.
• Manage certification processes for ISO, FDA, CE and other market‑specific approvals.
• Coordinate preparation and submission of technical files, declarations of conformity and audit documentation.
• Liaise with notified bodies, third‑party auditors and internal stakeholders to address audit findings.
• Analyze regulatory updates and integrate them into product lifecycle and certification strategies.

Required profile

• Bachelor’s degree in Engineering, Biomedical Science, Quality Management or a related field.
• 5–8 years of experience in regulatory affairs or certification, preferably in manufacturing, healthcare or industrial sectors.
• Strong understanding of UAE, GCC and international regulatory frameworks.
• Proven project‑management ability and high attention to detail.
• Excellent stakeholder‑engagement and proactive problem‑solving skills.

Required skills

• ISO 9001
• ISO 13485
• FDA compliance
• CE marking
• Regulatory frameworks (UAE, GCC, International)
• Technical file preparation
• Declarations of conformity
• Risk management standards