Quality & Regulatory Specialist at SOFMEDICA

Sofia, Sofia-City, Bulgaria -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

0.0

Posted On

15 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, ISO 9001, ISO 13485, ISO 14001, Complaint Handling, Non-Conformities, Supplier Qualification, Regulatory Compliance, Internal Audits, External Audits, Risk Management, Continuous Improvement, Effective Communication, Teamwork, Attention To Detail, Dynamic Learning

Industry

Medical Equipment Manufacturing

Description

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. 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 Hungarian and English 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.

Responsibilities

The Quality and Regulatory Specialist will manage and maintain the company's Quality Management Systems in accordance with relevant standards and oversee the handling of complaints and non-conformities. They will also supervise supplier qualification and coordinate communication with regulatory bodies.