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  • Completed education with a legal, technical, or scientific focus (e.g., Law, Medical Technology, Biomedical Engineering, Computer Science, University of Applied Sciences or University degree).
  • Basic knowledge or initial experience in Regulatory Affairs for medical devices.
  • Interest in cybersecurity, artificial intelligence, and their regulatory classification.
  • Understanding of regulatory frameworks such as MDR, ISO 13485, IEC 62304, IEC 81001-5-1, ISO 14971, and the EU AI Act is an advantage.
  • Structured, analytical working style with high attention to detail.
  • Very good German and English skills.
  • Strong communication skills and enjoyment of interdisciplinary collaboration.

  • Support development and customer projects in meeting regulatory requirements related to cybersecurity and AI for medical device software.
  • Contribute to the interpretation and implementation of international regulatory requirements
  • Support regulatory assessments, documentation, and evidence generation.
  • Collaborate with project management, software development, quality management, and external partners.
  • Contribute to building, further developing, and maintaining processes and policies related to cybersecurity and AI regulations.
  • Support the organizational implementation of new regulatory requirements (e.g., EU AI Act, international regulations).
  • Help raise organizational awareness of regulatory requirements.
  • Support internal audits and regulatory-related topics.

The annual salary is 53.802€ gross on a full-time basis according to the IT collective agreement.
Willingness to pay more based upon qualifications and experience.

Instead of corporate policy, you will find collaboration with committed people on an equal footing. Mutual respect and appreciation are very important to us. Our family-like working environment provides the framework for close teamwork and allows sufficient freedom for the individual development of all employees. In the right environment, work is fun—our benefits play a secondary role.

Gruppenfoto vor KLS MARTIN WORLD