Job Opportunities API

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 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 maintain the company’s  Quality Management Systems (QMS)  in accordance with  ISO 9001, ISO 13485, ISO 14001 , and other relevant standards. Oversee the  handling of complaints and non-conformities , ensuring timely investigation, documentation, and implementation of corrective and preventive actions. Manage and control  certificates, technical documentation, and quality records  to ensure compliance and traceability. Supervise  supplier qualification, evaluation, and contract management , maintaining strong relationships and ensuring compliance with quality and regulatory requirements. Coordinate and maintain effective  communication with competent authorities  and regulatory bodies. Participate in internal and external audits , supporting preparation, execution, and follow-up of audit activities.