Regulatory Affairs Manager (m/f)

REFERENZNUMMER:

361524/5

IHRE AUFGABEN:

-Providing Regulatory Affairs support for one of the company’s European Authorised Representatives (EAR)
-Filing and maintaining medical device registrations in the relevant German national database, maintaining internal documentation and communicating registration information to relevant stakeholders
-Assist with all responsibilities held by the European Authorised Representative based in Germany
-Maintain internal databases of currently registered medical devices
-Prepare status updates for senior management on the progress of medical device registrations completed in Germany for the EAR
-Access the UMDNS database to identify and allocate codes/terms to the company’s existing medical devices
-Navigate internal electronic systems to locate regulatory documentation and data
-Navigate internal regulatory documentation to identify and extract data needed for EAR registrations
-Coordinate with other internal stakeholders to locate cross-functional data and where needed, review and feedback on compiled data and documentation
-Generate and maintain status reports on EAR activities to be provided to German authorities
-Submission of regulatory documentation and data into the German Regulatory system
-Keep EU affiliates informed about changes and forward documentation as needed

IHRE QUALIFIKATIONEN:

-Ability to use multiple complex databases simultaneously
-Ability to comprehend scientific and clinical data
-Ability to manage large amounts of data comprehensively
-Ability to interact with personnel across the organization, across departments and seniority
-Ability to interact professionally and diligently with government staff
-Ability to work independently and manage high workload efficiently
-German/English language fluently in writing and verbal
-Basic knowledge of European Medical Device Regulations (MDD, MDR, ISO 13485)

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager