Quality and Regulatory Affairs Manager

About the job

As a Quality Manager, you will:

  • Ensure that our processes and products meet all necessary requirements before they reach the users
  • Implement and maintain a Quality Management System (QMS) that complies with ISO 13485, ISO 14971 and FDA 510(k) 
  • Generation and maintenance of technical files
  • Communication with Notified Body and other responsible authorities

 

What you will bring along

  • Experience managing QM systems in accordance with ISO 13485, ISO 14971 and FDA 
  • At least five years of experience with QMS and regulatory affairs for in-vitro diagnostics 
  • Knowledge of in-vitro diagnostic medical devices regulation IVDD and CFR
  • Experience conducting internal as well as supplier audits
  • Thoroughness and strong attention to detail
  • A continuous improvement and problem-solving mentality
  • Effective communication and active listening skills
  • Fluent in English and German


What we offer

  • Competitive salary
  • Possibility to participate in the company's virtual stock options programme
  • Monthly coaching
  • Beautiful, central and dog-friendly office location in Berlin
  • An opportunity to work in a fast-growing startup that has developed its own innovative product
  • A fun and friendly work environment with a diverse group of motivated, talented, and visionary colleagues
  • Coffee, tea, fruits, chocolate and drinks with the team