Open role
QA & RA Officer
Panda International B.V.
About the role
QA & RA Specialist
A growing MedTech company is looking to strengthen its Quality & Regulatory Affairs team to support the expansion of its product portfolio across international markets. The QA/RA Specialist will help maintain the company’s Quality Management System and support regulatory activities to ensure continued compliance with global standards and regulations.
What you'll do
Maintain and support the ISO 13485-compliant Quality Management System, ensuring ongoing regulatory compliance
Support regulatory submissions and international product registrations across multiple markets
Manage quality processes including complaints, non-conformities, and CAPA activities
Support and coordinate internal and external audits and management review activities
Contribute to the preparation and maintenance of technical documentation and regulatory strategies
What you'll bring
Bachelor’s degree in science, engineering or a related field
2+ years of experience in QA/RA within MedTech or another regulated industry
Experience working within an ISO 13485 Quality Management System
Knowledge of regulatory submissions or product registrations (MDR, FDA or similar frameworks)
Strong communication skills in English