We are searching for
Regulatory and Quality Affairs Engineer
full-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

  • Assist with maintaining and improving Quality Management System, especially tool validation related activities to comply with ISO 13485, ISO 14971 and the MDR
  • Collect feedback from radiologists by moderating Usability Evaluation sessions internationally, especially with the focus on the Serbian, Russian, Australian and Canadian market 
  • Support planning and conducting Post-Market Surveillance for AI-based medical device products
  • Assist with internal audit and 3rd party audits 
  • Work on regulatory and quality affairs projects individually

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 45+ people.

What We Are Looking For

  • Bachelors and Masters in Life-Sciences, preferably Biomedical Engineering with IT & Machine Learning in focus
  • At least one year of experience working in the Quality & Regulatory field for AI/ML-based software as a medical device
  • Knowledge of applicable laws, standards & guidance documents for AI/ML-based software as a medical device such as ISO 13485 and the MDR
  • Experience with the maintenance of  continuous conformity with an existing CE certification, especially with regards to the coordination of translations of official documentation for medical devices into various EU languages
  • Experience with supporting EU market placement by coordinating Device Labeling, including Unique Device Identification (UDI) and EUDAMED
  • Preferably experience with supporting 510(k) FDA clearance of AI-based medical device software solutions by assisting in the preparation of documentation and a reader study
  • Experience with agile development processes such as Kanban & Scrum-based Product management tool such as JIRA, targetprocess
  • Fluent English, at least C1 level since the official language of the company is 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
2.925€ monthly for 38.5 hrs, 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…).