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.
Our mission is to nurture an innovation and education ecosystem, empowering healthcare providers to deliver exceptional patient care.
As Quality & Regulatory Specialist you will:
- 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 degree in a relevant field.
- Professional experience in a Quality Assurance / Regulatory Specialist role, preferably within a regulated industry (e.g., medical devices, pharmaceuticals, manufacturing, or environmental management).
- Proven experience in maintaining and improving ISO management systems.
- Strong understanding of quality management principles, risk management, and continuous improvement methodologies.
- Fluency in Greek and English.
Skills & Competencies:
- Excellent communication skills and ability to work effectively within a team.
- Well-organized, detail-oriented, and able to work in accordance with established procedures.
- Dynamic, fast learner with a proactive mindset.
- Accountable and responsible for delivering high-quality work.
Nice to have:
- A Master’s degree in Quality Management, Public Health, or Medical Devices would be considered an asset.
Benefits
- Competitive compensation and benefits package.
- Work in a unique innovative healthcare ecosystem, at multi-country European level, with high standards in our work environment and ethics.
- Opportunity for a solid career plan.
- Access to professional education programs and talent development.
- Opportunity to be part of a dynamic Team of professionals in eight countries.
SofMedica Group is an equal opportunity employer committed to workforce diversity.
