Tasks
Labelling & Translations
Drive labelling activities for assigned products in line with regulatory and market requirements.
Coordinate translations of labels, operator manuals, and software-related texts.
Ensure accuracy, consistency, version control, and timely implementation of updates.
Perform verification activities to confirm compliance with defined requirements.
UDI Management
Manage UDI activities for assigned products, including assignment, maintenance, and database updates.
Ensure alignment between UDI, labelling, and technical documentation.
Support UDI-related changes across the product lifecycle.
Quality & Compliance Support
Support PMS and risk management activities, ensuring alignment with labelling and IFU content.
Contribute to CAPA activities related to labelling, UDI, and product information.
Maintain quality records and support audits as required.
About the position
Your key role is to support design quality activities and product integrity by coordinating labelling, translations, and UDI management. As a Junior Design Quality Specialist, you contribute to essential quality and regulatory processes, including Quality Management, Risk Management, Post-Market Surveillance, and CAPA. You support the creation, maintenance, and accuracy of compliant product documentation and ensure it remains up to date throughout the entire product lifecycle, in close collaboration with cross-functional teams. Do you want to help us to make lung function testing accessible to everyone everywhere, and to improve the lives of millions of people with lung diseases? Then you have come to the right place!
Your profile
Bachelor's degree in biomedical engineering, life science discipline or comparable technical or scientific field.
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