Work Flexibility: Hybrid

12 months Fixed term contract

Position Summary

In your role as (Senior) Labeling und Technical Publication Specialist (m/f/d), you are the first point of contact for our internal and external customers in the field of labeling. You are responsible for the creation and maintenance of labeling documents (i.e. labels and instructions for use) for our high-quality medical devices per international regulatory standards and requirements while collaborating with various internal and external stakeholders. You are working in a world-class and quality-focused environment ensuring we are delivering proper information to our customers being able to use our devices safely.  

 

What you will do:Your main tasks include the creation and maintenance of the content and design of labeling (i.e., instructions for use and labels) per international regulatory standards, the coordination of the review and approval process, the translation management as well as the print release and publication.You support and manage as well internal New Product Development Projects, improvement projects, but also regulatory compliance projects, such as EU MDR, eIFU, CE marking through the entire lifecycle from preparation and planning through successful completion.You are also responsible for streamlining and optimizing processes and implementing new or changed regulatory requirements.You are responsible for managing NCs and CAPAs keeping our quality standard high.

 

What you will need?You have successfully completed a technical degree or gained a certificate in a related field (e.g. technical writer, engineer).You have many years of relevant professional experience in labeling, quality, regulatory affairs or R&D, ideally in the medical device, pharmaceutical or other regulated industries.You have experience in project management and are highly efficient in leading the process from creation to release. You have a keen interest in the implementation of projects as well as the creation and maintenance of high-quality documents.You are fluent in spoken and written English and ideally have excellent knowledge of German and/or French.You are a resilient, reliable and service-oriented person who enjoys working on complex issues in a qualitative and timely manner.You feel comfortable in an international work environment and can integrate easily into various (project) teams.

 

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Travel Percentage: 10%