Quality & Regulatory Specialist at SOFMEDICA

Municipality of Marousi, Attica, Greece -

Full Time

Start Date

Immediate

Expiry Date

20 Jul, 26

Salary

0.0

Posted On

21 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, ISO 9001, ISO 13485, ISO 14001, Regulatory compliance, Risk management, Continuous improvement, Technical documentation, Supplier qualification, Audit preparation, Communication, Detail-oriented, Proactive mindset

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. 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. 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. 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.

Responsibilities

The Quality & Regulatory Specialist will manage and maintain the company's Quality Management Systems in accordance with ISO standards. They will also oversee complaint handling, non-conformities, supplier qualification, and regulatory communication.