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.

You bring

  • 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.

You want

  • 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, work@decomplix.com.

Offers from recruitment agencies will not be considered.

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