Aufgaben

- Being responsible for regulatory aspects during the development of new VI products (regulatory strategy, applicable standards and guidelines)
- Registration of class III devices in the CE, US, and other highly regulated countries
- Coordinating and submitting deficiency responses to relevant certification bodies and country authorities
- Maintaining regulatory documentation up to date for worldwide regulatory purposes
- Worldwide assessment of changes and support production lifecycles activities
- Establishing and updating internal procedures to enable up to date and consistent output, as well as efficient workflow within the department and project team

Qualifikationen

- University degree in natural science, pharmacy, pharmacology, medicine or engineering
- At least 4 years of experience with registrations of class 3 medical devices including drug-device combination products in highly regulated countries, particularly in the CE region and the USA.
- Excellent knowledge of the applicable medical device regulations in the countries mentioned above, including current developments (MDR)
- Experience in project management
- Literate in Microsoft Office applications; SAP knowledge is an advantage
- Independent, reliable and communicative personality who can deliver high-quality work even under pressure and handle several projects simultaneously
- Fluency in the English language mandatory, German and any other language an advantage