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
· Preparation of MDR submission for class III combination products
· 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