Assist through the following: • Adherence to the management policy of the CeramTec Group • Compliance with rules of the quality management system ad associated standards and regulations • Preparation and maintenance of regulatory documentation for internal and external purposes, considering the regulatory requirements; including monitoring, analysis, and implementation of regulatory requirements • Support the Regulatory Affairs department with ongoing projects, focus on the US; analysis of applicable regulatory requirements; preparing / review of regulatory documentation for submission to authorities • Prepare clinical study-specific submissions as well as other required documents • Organization and management of clinical study data and documentation; support in preparation of related r