A leading manufacturing company specializing in high-precision medical devices for dental and clinical applications is seeking an experienced Quality Assurance & Regulatory Affairs Manager to join its team in Greece.
With a strong export footprint in international markets and a growing presence in regulated environments, the company places Quality and Regulatory Compliance at the heart of its operations. This role is critical to ensuring product safety, regulatory conformity, and operational excellence, enabling further global expansion.
Main Responsibilities:
- Develop, implement, and maintain the company’s Quality Management System in accordance with ISO 13485
- Ensure full compliance with MDR (EU Medical Device Regulation), as well as global regulatory frameworks such as FDA, MDSAP, and Health Canada
- Author, review, and maintain SOPs, policies, and technical documentation for Class I and/or Class IIa medical devices
- Lead risk management activities based on ISO 14971, and continuously improve the QMS
- Plan and conduct internal audits; coordinate and support external inspections by regulatory bodies
- Manage non-conformities (NCRs), CAPAs, and Change Control processes
- Oversee complaint handling, product investigations, and post-market surveillance
- Support validation and qualification of manufacturing equipment and processes (IQ/OQ/PQ)
- Define and monitor quality KPIs; promote a culture of continuous improvement and quality excellence
- Deliver training to internal teams on quality standards and regulatory requirements
- Prepare and submit regulatory documentation to authorities and maintain compliance across global markets
Requirements:
- At least 7 years of experience in Quality Assurance and/or Regulatory Affairs, preferably within medical devices or pharmaceutical manufacturing companies
- Proven track record of working within a regulated production environment
- University degree in a relevant scientific or technical discipline (e.g., Pharmacy, Engineering, Biology, Medicine)
- In-depth knowledge and hands-on experience with ISO 13485, ISO 9001, and ISO 14971 standards
- Experience in FDA, MDSAP, and EU MDR compliance
- Audit certification and experience with regulatory inspections (e.g., Notified Bodies, FDA, Health Canada, etc.)
- Proficiency in CAPA, root cause analysis (e.g., 5 Whys), and FMEA
- Strong command of the English language (written and verbal)
- Excellent organizational, leadership, and communication skills
This is an opportunity to join a fast-paced, innovation-driven company at the forefront of medical device manufacturing. If you are passionate about quality and regulatory excellence and have the required background in production environments within highly regulated industries, we would love to hear from you.
