(Senior) Labeling Engineer Medical Devices (80-100%)
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BIOTRONIK is a leading manufacturer of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology, and vascular intervention. Headquartered in Berlin, Germany, we develop, produce, and distribute high-quality medical products based on the latest technology and research. Our success is driven by the competence and results-oriented cooperation of our employees.
Our Packaging & Labeling Development (PLD) Department develops, validates, and implements global packaging and labeling solutions for the vascular intervention unit. The Labeling Engineer will reinforce the labeling team and help provide life-saving devices with compliant and cost-effective labeling components.
1. Bachelor’s or Master’s degree in a technical or scientific discipline
2. Ideally, you have experience in labeling development in a similar role, preferably in the medical device or pharmaceutical industry
3. Knowledge of labeling systems and understanding of labeling standards/regulations for medical devices are a strong plus
4. Reliable, responsible, with a collaborative mindset
5. Affinity for IT systems; familiarity with Adobe InDesign, SAP, and Content Management systems (e.g., ST4) is advantageous
6. Strong English language skills are essential; German language skills are a plus
7. As a Labeling Engineer, you will be the "End to End Owner" of Biotronik VI’s product labeling components
8. You will be responsible for developing, implementing, and maintaining labeling components such as product labels, instructions for use (IFU), information for patients (IFP), and product labels
9. You will collaborate with internal stakeholders like regulatory affairs, risk management, and clinical sciences to generate labeling content
10. You will ensure compliance with regulatory labeling standards (e.g., CE, FDA, TGA) and perform Gap-Analysis to implement regulatory requirements
11. As SME, you will represent the labeling department in internal and external audits
12. You will support BIOTRONIK’s digitalization strategy by providing labeling components across multiple digital platforms (e.g., eIFU)
If you are interested, please apply online through our application management system. We look forward to getting to know you.
Apply now at: www.biotronik.com/careers
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Engineering and Information Technology
Industries
* Medical Equipment Manufacturing
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