Quality & Regulatory Specialist

At SOFMEDICA, we believe that innovation only matters when it reaches the people who need it most.

Every product we register, every process we improve, and every quality standard we uphold helps healthcare professionals deliver better care and gives patients access to life-changing medical technologies.

We're more than a medical technology company - we are a tribe of passionate people driven by one purpose: changing lives through innovation.

As part of the SOFMEDICA Group, a leading education-driven healthcare organization operating across Europe since 1994, we work alongside world-leading MedTech partners to bring cutting-edge medical technologies closer to healthcare professionals and patients.

Now, as we continue expanding into Egypt, we're looking for a passionate and detail-oriented Quality & Regulatory Specialist to help build a strong, compliant, and trusted foundation for our business from day one.

If you're someone who believes quality is more than compliance and sees it as a commitment to patient safety and healthcare excellencem, we'd love to meet you.

As our Quality & Regulatory Specialist, you'll play a vital role in ensuring that every product we bring to the Egyptian market meets the highest standards of quality, safety, and regulatory compliance.

You'll help enable the introduction of innovative medical technologies while building processes that healthcare professionals can trust and patients can rely on.

Your work will directly contribute to improving healthcare outcomes across Egypt.

What You'll Be Doing

• Manage product registrations, renewals, variations, and regulatory maintenance activities in Egypt.

• Prepare, review, submit, and maintain regulatory dossiers and technical documentation.
• Monitor changes in Egyptian regulatory requirements and evaluate their impact on company products and operations.
• Build and maintain strong relationships with regulatory authorities, certification bodies, and other external stakeholders.
• Ensure product registrations, certificates, declarations, approvals, and technical documentation remain accurate, current, and audit-ready.
• Drive Quality Excellence

• Maintain and continuously improve SofMedica's Quality Management System (QMS) in accordance with applicable standards and local regulations.
• Ensure quality procedures, work instructions, records, and documentation are effectively implemented and maintained.
• Support complaint handling, CAPA activities, supplier qualification, risk management, and continuous improvement initiatives.
• Prepare the organization for internal and external audits while ensuring ongoing compliance.
• Collaborate Across the Business

• Provide expert regulatory and quality guidance to support strategic business decisions.

• Bachelor's degree in Pharmacy, Life Sciences, Engineering, Quality Management, Regulatory Affairs, or a related field
• Experience with Egyptian medical device regulations and registration processes
• Experience communicating directly with regulatory authorities or certification bodies
• Good understanding of Quality Management Systems
• Experience with documentation control, CAPA, audits, supplier qualification, and complaint handling
• Strong organizational skills and exceptional attention to detail
• High level of integrity, accountability, and professionalism
• Excellent communication and stakeholder management skills
• Passion for continuous improvement and process optimization
• Fluency in Arabic and English

By joining SoFmedica, you'll enjoy the opportunity to:

• Be part of the launch and growth of SofMedica Egypt.
• Work with world-leading medical technologies that transform patient care.
• Collaborate with experienced international teams across Europe and the region.
• Access continuous learning and professional development opportunities.
• Grow your career within a fast-growing, purpose-driven healthcare organization.
• Be part of a collaborative culture built on trust, innovation, agility, and continuous improvement.

This is more than your next career move, it is an opportunity to help shape the future of healthcare in Egypt.

If you are passionate about quality, inspired by innovation, and ready to make a meaningful impact from the very beginning, we'd love to welcome you to the SOFMEDICA tribe.