Regulatory Affairs and Quality Manager for Artificial Intelligence Software as Medical Product (f/m/x)

We are a company that uses artificial intelligence to optimize processes in cancer diagnostics. Our mission is to make microscopic and pathological analysis accessible to all people worldwide.

 

We solve the urgent problem that the demand for medical image diagnosis is growing rapidly while the number of cancer specialists remains the same. With the help of our products, doctors spend less time on repetitive and monotonous tasks. Instead, they can focus on tasks where their particular human expertise remains indispensable.

 

Optimizing cancer diagnostics with machine learning is one of the most challenging tasks and requires the most capable minds. In our team you will work closely with industry experts in applied deep learning and company building. 

 

To help shape the future of cancer diagnostics, we are looking for you!

 

As Regulatory Affairs and Quality Manager you will be the interface between the development and marketing of artificial intelligence software products in the field of cancer diagnostics. You will accompany and shape the CE approval of our products according to IVDD and IVDR.

 

Your tasks:

  • In close cooperation with leading service providers, you will develop concepts for the development of QM systems and technical documentation in the field of image processing in pathology and implement these concepts independently, efficiently and precisely.
  • You will continuously improve our QM system for newly arising requirements.
  • You will develop processes that comply with the regulations for technical documentation as well as enable flexible software development.
  • You determine regulatory requirements.
  • You bring your own pragmatic ideas for implementing QM guidelines into the development of artificial intelligence software.

 

Your profile:

 

  • University degree in a relevant subject with a focus on analytical thinking and precise, reliable working methods (or professional experience in the field of Regulatory Affairs & QM)
  • Ideally, experience in setting up and further developing QM systems, and/or successful support of an audit.
  • Ideally knowledge of standards and laws (EU) in the field of active medical devices (e.g. ISO 13485 and ISO 14971), especially of stand-alone software as a medical device, and enjoyment in applying and deepening this knowledge.
  • A high interest in software development or ideally even first experiences in programming.
  • Strong communication skills in dealing with health and regulatory authorities.
  • Enjoy working with legal texts and researching international guidelines and laws.

 

We offer:  

 

  • A modern workplace in an innovative industry
  • The possibility of taking cancer diagnostics to a new level
  • An open and creative working environment
  • Flat hierarchies and short decision-making processes 

 

We are looking forward to receiving your detailed application stating your availability and salary expectations by email at jobs@mindpeak.ai. Your contact person is Susanne Zander. You can also reach her under +49 40 / 356 76 798 if you have any questions (this number is reserved for applicants and does not apply to recruitment agencies). If you are not yet looking for a job, we will be happy to contact you via XING or Linkedin.