Regulatory Affairs

Overview

We are seeking a detail-oriented and experienced Regulatory Affairs Officer to join our team in Jeddah. The ideal candidate will be responsible for managing all regulatory activities related to medical devices and healthcare products, ensuring full compliance with SFDA (Saudi Food & Drug Authority) and other relevant authorities.

Responsibilities

• Prepare, submit, and follow up on MDMA (Medical Device Marketing Authorization) applications with SFDA.
• Coordinate and maintain product registrations, renewals, and variations in compliance with local regulations.
• Ensure all products meet SFDA, GHTF, IMDRF and international regulatory requirements.
• Liaise with suppliers, manufacturers, and distributors to obtain and compile regulatory documentation.
• Manage the importation process, including preparation and submission of clearance documents for shipment release.
• Follow up with customs brokers, clearing agents, and SFDA inspectors to ensure timely clearance of shipments.
• Ensure correct labeling, documentation, and product classification according to SFDA guidelines.
• Monitor regulatory updates, circulars, and announcements to ensure company compliance at all times.
• Assist in audits, inspections, and internal compliance reviews.
• Maintain a regulatory database and proper filing system for all approvals, licenses, and permits.

Qualifications & Requirements

What We Offer

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