Expert (alle) Regulatory Affairs

Product authorisations (national and international) Creation and updating of authorisation documentation, submission of applications, communication with authorisation authorities Data management for authorisations and registration database Research, collection and communication of authorisation requirements Assessment of product changes and notification to regulatory authorities Monitoring of relevant regulations, laws, directives and standards

Complete studies in a technical direction, for example mechanical engineering, medical or electrical engineering or comparable training Knowledge of quality management standards ISO13485, European Medical Device Directive 93/42/EEC and Medical Device Regulation 2017/745 Knowledge of the approval of medical devices in the USA is desirable Applicable knowledge and experience in daily work with international regulatory requirements for medical devices Ability to structured and transparent thinking paired with communication strength Secure knowledge of English in word and writing

We offer the following benefits for an interesting and varied activity in a dynamic environment: High design playroom and work in an open team at eye level flat hierarchies and short communication paths Modern working environment and modern workplace design A comprehensive training Flexible working hours and models in full and parttime Operational health management incl. fitness room Kindergarten grant etc. .