Job Description

Roles & Responsibilities

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.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

• Apply only through official Medtronic channels.
• All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
• Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
• If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
• If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [اضغط هنا لمشاهدة البريد اﻹلكتروني] .

Benefits & Compensation

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).

Desired Candidate Profile

Required Knowledge and Experience:

• Bachelor s 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.