Labeling Engineer Medical Devices
vor 2 Wochen
Job description:
- As Labeling Engineer you are "End to End Owner" of Biotronik VI's product labeling components
- Responsible for the development, implementation and maintenance of labeling components such as product labels and instructions for use (IFU), information for patients (IFP) and product labels
- Collaborate with internal stakeholders such as regulatory affairs, risk management and clinical sciences to generate labeling content
- You ensure compliance to regulatory labeling standards (e.g. CE, FDA, TGA) and know how to put regulatory requirements into practice (e.g. perform Gap-Analysis)
- As SME you represent the labeling department in internal and external audits
- You support the digitalization strategy by providing labeling components on multiple digital platforms online (e.g. eIFU)
Profile description:
- Bachelor/Masters degree in a technical/scientific discipline
- Ideally you have gathered labeling development experience in a similar role, preferably in the medical device industry or in the pharma industry
- Knowledge of labeling systems and understanding of labeling standards/regulations for the medical device industry are a strong plus
- Reliable, responsible person with a collaborative mindset
- Affinity for IT-systems and familiarity with Adobe InDesign, NiceLabel, SAP and Content Management (ST4) systems are an advantage for the role
- Good skills in English are key to the role, German is a great addition
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