Software Compliance Manager Medical Devices (F/M), German & English (60% or more)
Decomplix 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. In times of more stringent regulatory hurdles, this business model 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 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.