Regulatory Affairs Manager (m/f)

Description

• 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

• 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)