Regulatory and Clinical Affairs Manager (w/m/d)

CeramTec is a leading developer and globally active manufacturer and supplier of high-performance ceramic solutions with more than 3,800 employees. Our solutions are used throughout the world in motor and mechanical engineering, medical technology, electronics, air and space technology and energy and environmental technology. Welcome to the ceramic experts. For our Medical Department at the Plochingen site in Stuttgart we are looking for Manager (m/d)

In this position, you are responsible for conducting clinical trials in the core area of the USA; this includes preparation, documentation and organization of study data. They are responsible for the scenario planning of the studies and support the selection of suitable designs. They form the central interface for communication with the Contract Research Organization (CRO) and other relevant partners to ensure smooth cooperation and to ensure the quality of the study. They support the implementation of authorisation projects, mainly in the USA. They are responsible for the analysis of the applicable regulatory requirements and for the preparation and verification of authorisation documentation for submission to the authorities.

They have completed their studies in the field of natural sciences, medical technology or comparable training. They bring well-founded experience in dealing with the requirements of 21 CFR 820, ISO 13485 and Good Clinical Practice (GCP). In addition, you already have experience in dealing with authorities and conducting clinical studies and product authorisations. Their very good knowledge of English allows you to communicate safely with our international colleagues, partners and authorities. A structured and independent way of working, a high level of quality awareness and the ability to precisely meet regulatory requirements are characteristic.

Flexible working hours Partnership work in the team Professional and personal development Occupational pensions and health programmes Business and employee events Canteen Mobile work possible Good access by public transport JobRad JOBV1_EN