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.
Requirements
- University graduate
- Experience in a Quality Assurance / Internal Auditor (SOX) role, preferably within a regulated industry (e.g., medical devices, pharmaceuticals, manufacturing, or environmental management). Regulatory Specialist experience can be advantage.
- Proven experience in maintaining and improving ISO management systems
- Strong understanding of quality management principles, risk management, and continuous improvement methodologies.
- Dynamic and fast learner
- Capacity to communicate effectively and the ability to work in a team
- Responsible for own work, well-organized, with attention to details, familiar to work according to the procedures
- Flexible to work in dynamic environment
- Fluent in Hungarian and English
Benefits
- Be part of a mission-driven team dedicated to improving healthcare.
- Opportunity for professional growth and continuous learning.
- A supportive and innovative work environment.
- Competitive salary, bonuses, and comprehensive benefits.
- Opportunities for professional development and career advancement within SOFMEDICA Group.