Career Center

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 reports for regulatory authorities • Interface communication with the CRO and other parties in context of clinical studies; support with clinical site monitoring as necessary • Preparation and assistance with site audits/inspections • Regulatory support of other departments, e.g. within Registration with FDA, Customs clearance or Medical Device Reporting • Support of monitoring and reporting legal requirements, such as registering, reporting and archival of non-conformities • Support of post study activities such as market surveillance, monitoring and adverse events reporting • Internal contact for regulatory issues as well as regulatory support of the departments, review of the relevant documentation from the departments with regard to regulatory aspects • Independent processing of additional projects / tasks in the area of Regulatory Affairs • Training and continuing education in the area of Regulatory Affairs • Regular access to confidential information • Compliance with all regulations and rules

• BS degree preferably in Engineering discipline • Previous experience working in Regulatory Affairs 3+ years, preferably medical devices • Knowledge of clinical trial documentation and regulatory requirements related to clinical trials is preferred • Knowledge of 21 CFR 820, ISO 13485 • Working knowledge of regulatory requirements for IDE, 510(k) • Strong written and verbal communication skills • Ability to manage projects, scopes, and timelines • Self-motivated and able to multi-task • Conduct tasks according to SOPs and processes • Works in a logical, structured manner and is detail-oriented • Team-oriented problem-solving ability • Ability to work effectively independently (home office) and as part of a team • Proficient in MS software and able to learn appropriate software • Excellent interpersonal and professional skills • Some travel possible • Remote work (home office) 50%