We are searching for
Regulatory and Quality Affairs Manager
full-time (f/m)

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 and are currently looking for someone to join our regulatory affairs and quality management team. You will have the unique chance to play a key role during the development of AI medical device software products and maintain and 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 Manager, you will

  • Coordinate and manage regulatory actions to file for CE certification and FDA approval of AI-based medical device software solutions 
  • Maintain and improve our Quality Management System and associated processes to comply with  ISO 13485
  • Ensure compliance with standards applicable to medical device software development, such as ISO 62304, 62366, 82304, 14971 etc
  • Coordinate and oversee risk management activities
  • Provide support for planning and supervising clinical trials in compliance with ISO14155
  • Ensure compliance with GDPR
  • Keep up to date with regulatory requirements

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
  • Work on the exciting topic of certification of AI software technology
  • Work directly with the founders and make meaningful contributions to company’s action and value
  • Manage your own time via flexible working hours
  • Enjoy other perks such as company retreats, discounted Vienna public transport monthly ticket, myclubs membership, etc.
  • Founded in 2016, we are one of the leading AI medical imaging startups, having grown to 18 people. To date, we have raised over 4 million € from VCs and EU grants and work together with renown customers across Europe.

What We Are Looking For

  • Experience in the certification of medical device software solutions
  • Broad knowledge of norms and standards relevant for medical device development
    (ISO 13485, 62304, 14971, 82304, 62366, 14155…)
  • Knowledge of the FDA approval process for medical devices
  • 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 in China and India

Gross salary starting from
3,000€ monthly, negotiable (+ potential share options)

We are an equal opportunities employer and value diversity! Females are strongly encouraged to apply!

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

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…).