Requirements
Bachelor's degree in Pharmacy, Life Sciences, Engineering, Quality Management, or Regulatory Affairs. Experience with Egyptian medical device regulations, registration processes, and direct communication with regulatory authorities or certification bodies. Understanding of Quality Management Systems, documentation control, CAPA, audits, supplier qualification, and complaint handling. Strong organizational skills, attention to detail, integrity, accountability, professionalism, and excellent communication skills.
Description
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 DoingManage product registrations, renewals, variations, and regulatory maintenance activities in EgyptPrepare, review, submit, and maintain regulatory dossiers and technical documentationMonitor changes in Egyptian regulatory requirements and evaluate their impact on company products and operationsBuild and maintain strong relationships with regulatory authorities, certification bodies, and other external stakeholdersEnsure product registrations, certificates, declarations, approvals, and technical documentation remain accurate, current, and audit-readyDrive Quality ExcellenceMaintain and continuously improve SofMedica's Quality Management System (QMS) in accordance with applicable standards and local regulationsEnsure quality procedures, work instructions, records, and documentation are effectively implemented and maintainedSupport complaint handling, CAPA activities, supplier qualification, risk management, and continuous improvement initiativesPrepare the organization for internal and external audits while ensuring ongoing complianceCollaborate Across the BusinessProvide expert regulatory and quality guidance to support strategic business decisionsRequirementsBachelor's degree in Pharmacy, Life Sciences, Engineering, Quality Management, Regulatory Affairs, or a related fieldExperience with Egyptian medical device regulations and registration processesExperience communicating directly with regulatory authorities or certification bodiesGood understanding of Quality Management SystemsExperience with documentation control, CAPA, audits, supplier qualification, and complaint handlingStrong organizational skills and exceptional attention to detailHigh level of integrity, accountability, and professionalismExcellent communication and stakeholder management skillsPassion for continuous improvement and process optimizationFluency in Arabic and EnglishBenefitsBy joining SoFmedica, you'll enjoy the opportunity to:Be part of the launch and growth of SofMedica EgyptWork with world-leading medical technologies that transform patient careCollaborate with experienced international teams across Europe and the regionAccess continuous learning and professional development opportunitiesGrow your career within a fast-growing, purpose-driven healthcare organizationBe part of a collaborative culture built on trust, innovation, agility, and continuous improvementThis 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.