Regulatory Affairs Manager (m/f/d) in-vitro diagnostic medical devices / CDx I 80-100%

Founded in 1994, regenold GmbH is today an international consulting and service company with more than 100 employees. We accompany customers worldwide in the development, admission and market access of medicines, food supplements and cosmetics, as well as medical products and in vitro diagnostics. We're looking for you as soon as possible Regulatory Affairs Manager (m/f/d) in-vitro diagnostic medical devices / CDx Part time / Full time (80-100%) Do you want to work with us? Then we should get to know each other!

Development and implementation of customized solutions to meet European regulatory requirements according to IVDR 2017/746 for a variety of customers such as diagnostic manufacturers, pharmaceutical companies or laboratories Regulatory support of development projects Compilation of technical documentation for a wide range of products, technologies and indications Responsive cooperation in a “high-performance” team Close cooperation with international customers and with designated bodies and authorities

Master's degree in molecular biology, biotechnology, biochemistry, molecular medicine, biomedical analysis, regulatory affairs with a focus on IVD or comparable At least two years of experience in the field of IVD Regulatory Affairs in the IVD industry or at a designated body / authority Finded knowledge of CE certification of IVD products (preferably reagents(kits)) Knowledge of the current regulatory requirements and regulations (relevant standards, MDCG, CLSI etc.) Excellent presentation and communication skills in direct customer contact Sovereign appearance and joy in direct interaction with customers Experience with the implementation of in-house tests according to IVDR Art. 5(5) and registration of performance studies is advantageous Excellent written and oral language skills in German and English Self-responsible operation and very good project management

Customer and solution orientation – for us the ''DNA' of a professional service provider Experience, expertise and globally active networking in more than 90 countries through the regulanet® network founded by us* Long-standing and innovative customers who are honestly recommending A team-crossing personal and active, living together An attractive, bright and modern working environment What you get International diversity – in the team and in the projects Multifaceted and complex projects that provide exciting and varied challenges every day Long-term perspective, professional and personal development, interesting tasks and individually tailored training opportunities Flexibility, freedom and self-responsibility – through flat hierarchies, short decision-making and family-friendly working time models, something for everyone ... Work in one of the most beautiful regions of the country, also known as the Tuscany of Germany, on the edge of the Black Forest in the Triangle Germany / France / Switzerland Remote work solutions possible after consultation Attractive salary, occupational retirement, asset-effective services, JobRad, Hansefit, Shuttle Transfer Freiburg-Badenweiler and much more, promised ...