Specialist Regulatory Affairs for Medical Devices (m/w/d)

With products characterized by quality and know-how, the owner-managed Swiss pharmaceutical company TRB CHEMEDICA AG, founded in 1996, has developed a leading position in the industry in the fields of orthopaedics and ophthalmology. The task of the German decree is to certify the medical devices and the distribution in Germany and the Benelux countries. In the coming years, the innovative company plans to introduce important innovations. Support our team in this exciting task! In order to support the Regulatory Affairs department, we are looking for a location in Feldkirchen near Munich as soon as possible Specialist Regulatory Affairs für Medizinprodukte (m/w/d)

In a team you work on: Preparation of approval dossiers for non-European authorisations for our Swiss parent company With the help of the creation and maintenance of the MDR-compliant technical documentation of TRB medical devices Editing and implementing design changes Preparation of packaging for medical devices, medicines and dietary supplements. This includes coordination with the design agency, the contract manufacturer and printer as well as the Swiss parent company Research and evaluation of new regulations in the medical device sector and implementation in technical documentation Compilation of batch documentation for market release

For this, you are not only characterized by your commitment and strong communication skills, but also by the following qualifications and characteristics: Medical-nature scientific expertise Successfully completed studies in the scientific field Ability to view, interpret and evaluate medical-scientific data and publications Ability to present and formulate scientific results and findings in English and German An at least two-year professional experience in the international approval of medical devices (class I to III) Professional experience in creating technical documentation in STED format – ideally under MDR requirements German and English in word and writing Their profile is rounded off by a high degree of communication strength, self-initiative, independent work and solution-oriented thinking.

In a team you work in the company as well as after successful integration in the home office. An interesting and versatile work area awaits you with: a living working culture with flat hierarchies the possibility to quickly take ownership and create something a kitchen and terrace overlooking the Zugspitze, which form the social center of the company; including free water, juice, coffee, tea and fruit Company events, Christmas and team building events a JobRad, corporate fitness and plenty of space for your suggestions on how to design our corporate culture 30 days a year a modern workplace in your own new company building in the Munich East JOBV1_EN