Senior Regulatory Affairs Manager (F/M/D), German & English (60% or more)
Decomplix is a compliance partner that simplifies market access for medical devices. As a legal manufacturer and Swiss Authorized Representative, Decomplix goes beyond consulting and assumes pre- and post-market responsibility. Increasing regulatory requirements are growing demand. For the expansion of our team, we are looking for a Senior Regulatory Affairs Manager (F/M/D), German & English (60% or more).
You take on
- oversight of the tasks relative to regulatory affairs applicable to medical devices and in-vitro diagnostic devices at Decomplix;
- provision of regulatory expertise, counsel, training, and interpretation of requirements to customer projects;
- generation and maintenance of Decomplix’ and customers’ compliant medical device Technical Documentation for CE-marking;
- compliance of related processes in Decomplix’ quality management system.
- a scientific or technical background;
- at least 10 years of professional experience in regulatory affairs in Medtech industry — within the EU and internationally;
- proficiency in EU legislation on medical devices (MDR/IVDR and MDCG guidance documents) and the related certification processes;
- attention to detail, customer focus, and passion for writing technical documents;
- very good knowledge of German and English, spoken and written.
- to simplify market access for developers, manufacturers and new technologies;
- to expand your regulatory affairs competence, by working with various companies and products;
- to take responsibility, cooperating to form and actively shape Decomplix;
- to work independently, entrepreneurially and flexibly as well as take on new tasks;
You get the chance,
- to be part of a growing and diverse team where individuality and creativity are valued and encouraged;
- to work in a flat structure with very flexible working hours in Bern and in the home office;
- to constantly develop yourself with new products and projects;
- to act in an environment where Regulatory Affairs and Quality Management are the core business.
Interested? We would like to get to know you. Send us your application file by e-mail to Beni Hirt, firstname.lastname@example.org.
Offers from recruitment agencies will not be considered.