Hybrid Quality & Regulatory Specialist

at SOFMEDICA Life-saving Innovation

• Job title: Quality & Regulatory Specialist
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Marousi, Greece

About the role

• Quality & Regulatory Specialist at SofMedica ensuring compliance with quality standards and managing quality management systems. Overseeing supplier qualifications and participating in audits.

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 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.