Regulatory Affairs Manager (m/f/d)

Implementation of conformity assessment procedures in accordance with the requirements of the MDR Development of product registration strategies and independent processing of international registrations (FDA, PMDA, TGA, etc.) Compilation of registration dossiers according to country-specific requirements Assessment of changes in the reporting and approval requirements of certified products and compilation and submission of necessary documentation Analysis of new regulatory requirements and coordination of implementation in close cooperation with interdisciplinary teams. Special responsibility for the consideration of regulatory aspects in product development projects Communication and coordination with designated bodies, cooperation partners, internal specialist departments and external service providers

Successfully completed engineering or natural science studies First experience in product approval of medical devices and knowledge of regulatory requirements desirable Interest in regulatory issues in the field of pharmaceuticals, biocompatibility, digital products, artificial intelligence and cyber security Ability to detail in a complex working environment with multiple and competing priorities Good communication skills and analytical thinking German and English skills

Attractive tariff containers (IG metal) incl. collective agreement fittings, like 30 days holiday Solid onboarding incl. Buddy program Jobticket and food grants as well as balanced food offer in several local canteens Occupational pension Mobile work and diverse health services A workplace with very good transport links and good parking Be part of a company that saves life with its medical devices Location: Berlin | Working time: full time (35 hours/week) | Type of contract: unlimited Disabled people are preferably taken into account with the same suitability. In principle, there is also the possibility of parttime employment. .