Salary: AED 20,000/- to AED 25,000/- + Benefits

Our client, a leading medical devices company, is looking for an experienced Regulatory Affairs Specialist to ensure compliance with UAE and international medical device regulations. The candidate will manage regulatory submissions, maintain approvals, and support cross-functional teams throughout the product lifecycle.

Key Responsibilities:

• Develop and implement regulatory strategies for medical devices in the UAE market.
• Prepare, review, and submit regulatory documentation to health authorities and other relevant bodies.
• Ensure compliance with UAE regulations and other international standards.
• Collaborate with R&D, Quality, Clinical, and Marketing teams to provide regulatory guidance.
• Monitor regulatory updates in the UAE and globally, assessing their impact on products and processes.
• Support inspections, audits, and interactions with regulatory authorities in the UAE.
• Review labeling, instructions for use, and promotional materials to ensure compliance.
• Provide regulatory input for product development, risk management, and post-market surveillance activities.

Qualifications & Skills:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field.
• 5–7 years of regulatory affairs experience in the medical devices industry, preferably in the UAE or GCC region.
• Strong knowledge of UAE medical device regulations, FDA, EU MDR, and ISO standards.
• Experience preparing regulatory submissions and managing approvals in UAE and international markets.
• Excellent communication, analytical, and problem-solving skills.
• Ability to manage multiple projects in a fast-paced environment and work collaboratively.