Worldwide assessment of changes and support production lifecycles 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
Being 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
Being responsible for regulatory aspects during the development of new VI products (regulatory strategy, applicable standards and guidelines)
Establishing and updating internal procedures to enable up to date and consistent output, as well as efficient workflow within the department and project team
Profile description:
University degree in natural science, pharmacy, pharmacology, medicine or engineering
First of experience with registrations medical devices
Knowledge of the applicable medical device regulations in the countries mentioned above, including current developments (MDR)
Literate in Microsoft Office applications; SAP knowledge is an advantage
Reliable and communicative personality
Fluency in the English language mandatory, German and any other language is an advantage
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