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%
CeramTec is a manufacturer and supplier of technical ceramics since 1903 and is active at production sites in Europe, USA and Asia with more than 3,680 employees worldwide. Well over 10,000 products, components and parts made by the ceramic experts are used in a wide range of applications. We develop and produce customer-specific medium and large series made of various ceramic materials tailored to customer requirements. Discover with CeramTec the world of advanced ceramics and one of the most powerful materials of our time.