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..

Requirements

• 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.

Benefits

We offer a competitive compensation and benefits package, professional development opportunities, and the chance to work in a dynamic international environment.