Software Compliance Manager Medical Devices (F/M), German & English (60% or more)
Decomplix is a compliance partner that simplifies market access for medical devices. As a legal manufacturer, Decomplix goes beyond just consulting. Proven experts guide developers and manufacturers through the CE certification. In times of more stringent regulatory hurdles, this offering provides Decomplix customers with legal protection, lower risks, and shorter time-to-market. Quality management and regulatory affairs are our core competence. For the expansion of our small core team, we are looking for a Software Compliance Manager Medical Devices (F/M), German & English (60% or more).
You take on
- the responsibility for the development and continuous improvement of Decomplix’ processes for medical device software (MDSW) lifecycle management;
- project management to bring the technical documentation of customers’ MDSW to the point where they can obtain the CE mark;
- the compliance of related processes in Decomplix’ quality management system;
- regulatory support to internal initiatives to improve our services to customers.
- a scientific or technical background;
- at least 10 years of professional experience in the Medtech industry, preferably in quality management or regulatory affairs or MDSW design & development;
- proficiency in IEC 62304, ISO 82304-1, IEC 62366, and the certification of MDSW in Europe;
- attention to detail, customer focus, and enthusiasm for writing technical documents;
- good knowledge of German and English, spoken and written.
- 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 also take on new tasks;
- to contribute to the improvement of patients’ health with new technologies.
You get the chance
- to work in a company where medical device compliance is part of the core business;
- to be part of a growing company with a unique business model;
- to adapt constantly and quickly to new products, processes, and projects;
- to collaborate in a flat structure and with flexible working hours in Bern and remote.
We would like to get to know you. Send us your application file by email to Beni Hirt, firstname.lastname@example.org.
Offers from recruitment agencies will not be considered.