We are searching for
Regulatory and Quality Affairs Engineer
part-time (f/m/d)

contextflow is an award-winning startup developing artificial intelligence-based software applications to support radiologists during their clinical routine. We are an ISO 13485:2016 certified medical device company developing MDR certified medical device software systems and are currently looking for someone to join our Regulatory Affairs and Quality Management team. You will have the unique chance to support the development of AI medical device software products and to make our existing Quality Management System more efficient. As the company is growing and expanding to international markets, we also provide a great learning opportunity.

As a Regulatory and Quality Affairs Engineer, you will

  • Work on regulatory and quality affairs projects individually
  • Support international market placement and the coordination and management of regulatory actions to file for CE certification and FDA approval of AI-based medical device software solutions 
  • Assist in maintaining and improving our Quality Management System and associated processes to comply with ISO 13485 and the MDR

What you can expect

We put huge emphasis on the well being of all our team members. We take care and support each other so that we can grow together. We work hard but also enjoy spending time together. Every second Thursday, we have Happy Hour together. Feel free to ask about it in more detail in your interview : – )

  • Become part of a team of AI medical image processing experts
  • Thrive in a young, dynamic learning environment where you can grow
  • If you want to write a Bachelor or Master thesis in cooperation with us, we are happy to support you there as well
  • Manage your own time via flexible working hours
  • Founded in 2016, we are one of the leading AI medical imaging startups, having grown to 30 people.

What We Are Looking For

  • Motivated student or part-time employee willing to learn and support the team
  • Background in IT, Biomedical Engineering or any another relevant scientific discipline
  • Structured work style and high level of self-motivation
  • Work permit in EU
  • Fluency in English
  • Strong belief in growing together as a team
  • Empathy for each other

Bonus Skills

  • Experience with agile development processes
  • Knowledge of regulatory requirements for medical devices

Gross salary starting from
1260€ monthly, negotiable based on qualifications

We are an equal opportunities employer and value diversity!

Join an award-winning team

  • Science & Business Award 2016 – Rudolf Sallinger Fonds
  • Most Promising Startup 2016 – BCS Search Industry
  • Digital Innovation Award 2017 – Austrian Federal Ministry of Education, Science and Research
  • Philips HealthWorks 2018 – Chosen as one of 19 participants out of 700+ applications
  • Best Pitch 2019 (Healthcare) – Pioneers Festival
  • Best Healthtech Startup 2019 (Austria) – Central European Startup Awards
  • Forbes AI30 DACH 2020
  • WKO Born Global Champions 2021

How to apply
Interested? Send an email to jobs@contextflow.com with max 1500 characters (~ half a page), letting us know why you would like to join contextflow and how you can best contribute.

Please provide links or attachments with information about yourself (CV, LinkedIN, Xing, website, github…).