Quality & Regulatory Specialist

SOFMEDICA Life-saving Innovation · Cairo, Egypt · Posted 2026-05-29

SofMedica is part of SOFMEDICA Group, an education-driven healthcare group active in Europe since 1994, with operations across Romania, Greece, Hungary, Bulgaria, Cyprus, Croatia, and Slovenia. The Group provides innovative medical technologies and aims to bridge the gap between the latest MedTech breakthroughs, healthcare professionals, and patients. Through its mission of making life-saving technologies accessible and empowering healthcare professionals through innovation and learning, SofMedica contributes to sustainable progress in healthcare systems and patient care. As we open SofMedica Egypt, we are looking for a passionate and detail-oriented Quality & Regulatory Specialist to help build a strong, compliant, and reliable foundation for our operations in the Egyptian market.Responsibilities:Manage and coordinate the registration, renewal, variation, and maintenance of product registrations in Uzbekistan.Prepare, review, submit, and follow up on regulatory dossiers and required documentation with competent authorities.Monitor changes in local regulatory requirements and assess their impact on company products and operations.Maintain effective communication with regulatory authorities, certification bodies, and other relevant institutions.Ensure that product certificates, technical documentation, declarations, approvals, and registrations are accurate, valid, and properly archived.Support the business with regulatory advice related to product launches, imports, distribution, labeling, and documentation requirements.Manage and maintain the company’s Quality Management System in accordance with standards. internal procedures, and applicable regulatory requirements.Ensure quality processes are properly documented, implemented, monitored, and continuously improved.Maintain quality records, procedures, work instructions, forms, certificates, and technical files to ensure compliance, traceability, and audit readiness..RequirementsUniversity degree in Pharmacy, Life Sciences, Engineering, Quality Management, Regulatory Affairs, or a related field.Previous experience in regulatory affairs, quality assurance, product registration, or compliance, preferably in medical devices, pharmaceuticals, healthcare, diagnostics, or another regulated industry.Good understanding of Quality Management SystemsKnowledge of regulatory requirements in Uzbekistan would be a strong advantage.Experience with documentation control, complaint handling, CAPA, audits, and supplier qualification.Experience communicating with competent authorities or certification bodies is preferred.High level of integrity, accountability, and confidentiality.Proficiency in Microsoft Office and document management tools.Fluency in Arabic and good command of EnglishAt SofMedica, we believe that innovation in healthcare only creates real impact when it reaches the professionals and patients who need it most.As Quality & Regulatory Specialist, you will play a key role in helping SofMedica Egypt bring high-quality, compliant, and innovative medical technologies to the market.Apply now and be part of SofMedica Egypt’s journey from the very beginning!

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