Job Description

Roles & Responsibilities

We are seeking a motivated and detail-oriented Associate Regulatory Affairs Specialist to join our pre-market team for Saudi Arabia. This role offers an excellent opportunity to build foundational experience in regulatory submissions and product registration activities in compliance with Saudi Food and Frug Authority (SFDA) requirements. The position provides hands-on exposure to cross-functional collaboration and regulatory processes, supporting the preparation and submission of high-quality documentation. It is ideal for candidates looking to develop their regulatory expertise and grow within a dynamic environment

This role is based in Egypt and involves close collaboration with local and global teams, including regulatory, commercial, and supply chain functions. It is primarily office-based, with limited travel as required.

Responsibilities may include the following and other duties may be assigned:

• Manage and execute product registration/renewals activities for Medtronic products in compliance with SFDA requirements and timelines to support timely market access
• Prepare, review, and submit regulatory documentation to ensure accuracy, completeness, and alignment with authority Technical File (TF) requirements
• Coordinate with global teams, legal manufacturers, and internal stakeholders to obtain required documents and align on submission timelines and implement submission strategies
• Monitor submission status, respond to authority inquiries, and ensure timely closure of regulatory actions
• Identify potential risks or gaps in documentation and escalate critical issues to ensure smooth approvals
• Maintain regulatory records and ensure all data and documentation are properly organized, traceable and compliant.

Desired Candidate Profile

• Bachelor s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or a related field
• 1-2+ years of experience in regulatory affairs, preferably within the medical devices or healthcare industry
• Good knowledge of SFDA Medical Device regulations, submission processes, and regulatory requirements in Saudi Arabia, with fully understanding of Technical File structure
• Experience in preparing and managing technical documentation and regulatory submissions
• Strong coordination and communication skills with the ability to work across cross-functional and global teams
• Detail-oriented with strong organizational skills and the ability to manage multiple tasks and deadlines.
• Prior experience in regulatory submissions within the medical devices industry, familiarity with SFDA electronic systems.
• Proficiency in Microsoft Office tools (particularly Excel, Word, and PowerPoint) and experience working in a fast-paced, matrix organization would further support success in this role.