CAREERS

Our portfolio companies are always looking for great people. Apply to the opportunities below or send us your profile.

Head of Regulatory Affairs at Kaia Health
Munich, DE
Kaia is a mission focused medical technology company:
In 2016 we set out with the mission to make effective, evidence-based therapies available to patients who suffer from chronic diseases. As back pain is the number one cause of disability worldwide with over 1 billion affected people, we built our first product, a clinically-proven mind-body therapy app, to help people with back pain.
 
The role encompasses:
Today we have more than 250.000 users across multiple apps and deployments. We are in the market as with two stand-alone software solutions regulated as  medical devices in the EU and have a certified QM system according to ISO 13485 since 2016.
 
  • You will interact with the Tech team, the Medical team and external advisors to set up proper technical documentation of Kaia’s products for regulation in the EU and USA
  • You take ownership of the international regulatory strategy for Kaia’s products together with the Chief Technical Officer and the Chief Medical Officer
  • You take ownership of Kaia’s Quality Management System to make processes compliant with EU and US/FDA regulations 
  • You make sure that the individual teams work according to relevant medical device manufacturer regulations in cooperation with team leaders
 
Your profile:
  • 3+ years experience in regulatory affairs for medical devices, preferably in stand-alone software as a device 
  • Experience with Quality Management Systems compliant with the ISO 13485, ideally also compliant with 820 CRF part 21
  • Ability to own regulatory processes at the interface of development, clinical and business teams 
  • Systematic problem-solving approach, coupled with strong english writing skills and a sense of ownership and drive
 
Ideally you also have:
  • Experience in small and scaling enterprises
  • A university degree in a relevant area
  • Understanding of the most fundamental machine learning concepts
 
You'll fit in with our company culture if you also:
  • view technology as a tool to improve a user’s life
  • have a bias for action; the world is complex and unpredictable place so starting, releasing fast, and getting feedback iteratively is the only possible path to success
  • strive to be articulate and humble, make the complex, simple, present ideas openly, accepting that being wrong is part of the process
  • thrive in an entrepreneurial team, adapt easily to change, and enjoy a fast-paced environment
 
Some of the benefits we offer:
  • Directly shape the future of digital health
  • A workplace in the city center of Munich with good connections
  • Flat hierarchies, flexible vacation and working times
  • Mario Kart in the office :-) 



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