Regulatory Affairs Specialist (m/f)

REFERENZNUMMER:

362988/4

IHRE AUFGABEN:

-Check if devices to be covered by the particular STED section are all considered
-Check if documents mentioned in the particular section are current and accurate
-Check if information available in the TFI has been integrated into the STED
-Check if STED section narrative and summaries of the referred documents concur
-Check if justification for compliance to current standard is available
-Check if the provided information in the particular section is supported with data
-Update Regulatory Affairs SOPs
-Issue and follow-up of change requests
-Review of submission files for accuracy of data
-Provide affiliates with appropriate documents for new registration and renewals
-Support the R&D Department as needed
-Issue and follow-up of change requests
-Update of R&D SOPs
-Write rationales and justifications

IHRE QUALIFIKATIONEN:

-Bachelor degree or higher in Natural Sciences
-Experience in Regulatory Affairs in medical device industry
-Fluency in English and German (both written and spoken)

WEITERE QUALIFIKATIONEN:

Technical writer