Do you thrive in a dynamic environment where regulations meet innovation? As an all-round QA/RA Specialist, you will join a committed QA/RA team (8 colleagues strong) and play a key role in maintaining and enhancing the quality and regulatory standards of our In-Vitro Diagnostic Medical Devices.

Together with the team, you’ll:

• Support product development and product change processes—from design transfer to implementation
• Maintain and update quality processes, ensuring continued compliance and operational excellence
• Support the controlled release of documents by managing document control processes
• Contribute to CAPA management, root cause analysis, and trend monitoring
• Register new products and liaise with OEM manufacturers, distributors, and global authorities
• Actively participate in internal and external audits