Regulatory Affairs Coordinator Full Time

About Us:

AZM for Trading and Distribution, a proud member of the EVA Group, is a leading provider of advanced medical solutions dedicated to improving patient outcomes and enhancing healthcare delivery across Egypt. We proudly represent world-class international brands such as Boston Scientific and Johnson & Johnson, delivering cutting-edge medical devices and solutions to hospitals and healthcare professionals.

Position Overview :

We are seeking a detail-oriented and proactive Regulatory Affairs Coordinator to support the regulatory operations of our medical devices portfolio. The role is responsible for coordinating product registrations, maintaining regulatory documentation, ensuring compliance with local regulatory requirements, and facilitating communication with regulatory authorities and internal stakeholders. This position plays a critical role in ensuring timely market access and uninterrupted supply of medical devices across Egypt.

Responsibilities:

• Prepare, compile, and submit regulatory dossiers and documentation required for product registration, renewals, amendments, and variations.
• Coordinate with the Egyptian Drug Authority (EDA) and other relevant regulatory authorities to support registration and compliance activities.
• Track and follow up on regulatory submissions, approvals, renewals, and regulatory commitments to ensure timely completion.
• Maintain and organize regulatory files, licenses, certificates, and product documentation in compliance with company and regulatory requirements.
• Review regulatory documents received from manufacturers and suppliers to ensure completeness and compliance with local regulations.
• Coordinate with international manufacturers to obtain required regulatory documents and technical files.
• Support importation and customs clearance activities by providing regulatory documentation and approvals as required.
• Ensure compliance of all medical devices with applicable local regulations, standards, and registration requirements.
• Monitor changes in regulatory requirements, guidelines, and policies affecting medical devices and communicate updates to relevant stakeholders.
• Assist in preparing responses to regulatory authority inquiries and requests for additional information.
• Support internal and external audits, inspections, and quality system requirements related to regulatory affairs.
• Collaborate with Sales, Marketing, Supply Chain, Quality, and Operations teams to ensure regulatory compliance throughout the product lifecycle.
• Maintain regulatory databases and generate periodic status reports for management review.

Skills & Requirements:

• Bachelor’s degree in Pharmacy, Science, Biomedical Engineering, Biotechnology, or a related healthcare field.
• 1–3 years of experience in Regulatory Affairs, preferably within the medical devices, healthcare, or pharmaceutical industry.
• Knowledge of Egyptian regulatory requirements for medical devices and registration processes.
• Familiarity with EDA regulations, importation requirements, and regulatory documentation.
• Strong organizational skills with excellent attention to detail.
• Ability to manage multiple projects and deadlines effectively.
• Strong communication and coordination skills.
• Proficiency in Microsoft Office applications.
• Good command of written and spoken English.

Why join AZM?

• Be part of a company at the forefront of medical innovation in Egypt.
• Exposure to international medical brands like Boston Scientific and Johnson & Johnson.
• Competitive salary and benefits package.
• Opportunities for professional growth and career development.
• Supportive and dynamic work environment.

• AZM is an equal opportunity employer and values diversity in the workplace.