Regulatory Affairs Manager (m/w/d)

You don't want to leave your career development to chance? Then go the next step with us. As one of the leading European platforms for technology services, FERCHAU brings together the smartest and most innovative minds with companies of various industries. We are looking for you: as an ambitious colleague, who wants to bring technologies to the next level. We implement exciting projects for well-known customers in all areas of technology and for all industries and convince daily with sound expertise and professional know-how. As a professional:r you support your colleague with your long-term expertise and expertise.

Projektmanager (m/w/d) Tutors Coordination and implementation of the authorisation of products in the EU and international markets Creation of approval documents Supporting the development department in creating and maintaining product files Working with the introduction of new processes (MDR 2017/745) Ensuring compliance with regulatory requirements Support in the development of authorisation strategies according to country-specific requirements Conformity assessment according to Medical Device Directive Testing and evaluation of product changes relevant to authorisation Our Services Occupational pension Unlimited employment contract Flexible working time design through sliding time regulations, part-time opportunities and, in some cases, trust work time Stay Fit with a Benefit for Fitness First More than the BAP: We offer special holidays, kindergarten grant, anniversary grants etc. Assets

This brings you successfully completed technical or scientific studies or comparable qualification Knowledge of product approval of medical devices and regulatory requirements (e.g. MPG, MDD/MDR, AIMDD, FDA) Knowledge of standards ISO 13485, ISO 14971 of advantage Specialized knowledge in the field of medical-technical products Experience in the production of technical documentation Teamability and Communication Strength Very good knowledge of German and English