Regulatory Affairs Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.

We are seeking a detail-oriented and motivated Regulatory Affairs Specialist to join our pre-market team for Saudi Arabia. This role offers an exciting opportunity to support product registration activities and contribute to timely market access in compliance with Saudi Food and Drug Authority (SFDA) requirements. The position provides strong exposure to regulatory processes and cross-functional collaboration working closely with local and global stakeholders. It is ideal for candidates looking to develop their regulatory expertise while playing a key role in ensuring high-quality submissions in a fast-paced 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 in compliance with SFDA requirements and timelines
• Prepare review and submit regulatory documentation to ensure accuracy completeness and alignment with authority expectations
• Coordinate with global teams legal manufacturers and internal stakeholders to define 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 documents are properly tracked updated and compliant
• Ability to collaborate with global cross-functional teams and proactively propose ideas and initiatives to improve Regulatory Affairs processes and efficiency.

Required Knowledge and Experience:

• Bachelors degree in Regulatory Affairs Life Sciences Biomedical Engineering or a related field
• 3-5 years of experience in regulatory affairs within the medical devices or healthcare industry
• Strong knowledge of SFDA regulations pre-market submission pathways and regulatory compliance requirements in Saudi Arabia
• Proven experience in managing complex regulatory submissions and defining submission strategies independently
• Demonstrated ability to lead cross-functional coordination with global teams legal manufacturers and external stakeholders
• Excellent analytical organizational and problem-solving skills with the ability to manage multiple priorities and meet tight regulatory timelines.

Prior experience in regulatory submissions within the medical devices industry familiarity with SFDA electronic systems and exposure to global regulatory environments are considered advantageous. 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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

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Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).