We are searching for Regulatory and Quality Affairs Engineer
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
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 email@example.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…).