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* Worldwide assessment of changes and support for production lifecycle activities
* Maintaining regulatory documentation up to date for worldwide regulatory purposes
* Registration of class IIb, IIa devices in the CE, US, Japan, and other highly regulated countries
* Responsible for regulatory aspects during the development of new VI products (regulatory strategy, applicable standards, and guidelines)
* Coordinating and submitting deficiency responses to relevant certification bodies and country authorities
* Establishing and updating internal procedures to ensure up-to-date and consistent output, as well as efficient workflow within the department and project team
* University degree in natural sciences, pharmacy, pharmacology, medicine, or engineering
* First experience with medical device registrations
* Knowledge of applicable medical device regulations in the mentioned countries, including current developments (MDR)
* Literate in Microsoft Office applications; SAP knowledge is an advantage
* Reliable and communicative personality
* Fluency in English mandatory; German and other languages are advantageous
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Legal
Industries
* Medical Equipment Manufacturing
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