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 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 / 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 **.
• 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 Bulgarian and English

Offer:

• 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.