Quality & Regulatory Specialist

SOFMEDICA is a leading regional multinational company that distributes innovative medical equipment harnessing the power of precision to improve healthcare outcomes. We are deeply committed to bridging the gap between cutting-edge medical technology and patients in Central and Southeastern Europe. We are lexpanding our operations in Uzbekistan and we are looking for a Quality and Regulatory Specialist to join our team and contribute to the quality and compliance of our medical devices. 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..

University 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 Systems Knowledge 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 Uzbek and/or Russian; good command of English is preferred.

We offer a competitive compensation and benefits package, professional development opportunities, and the chance to work in a dynamic international environment. The role provides strong exposure to regulatory affairs, quality management systems, audits, supplier quality, and product compliance, with opportunities for continued career growth within the organization.