We are searching for Regulatory and Quality Affairs Manager – full-time (f/m)
contextflow develops next-gen, deep learning-based tools to improve radiology workflows. Our 3D image-based search engine puts the knowledge encoded in millions of images at radiologists’ fingertips…fast. Nerds welcome.
As a Regulatory and Quality Affairs Manager, you will
Take over the regulatory actions to file for CE certification and FDA approval of a class 2 medical device software solution.
Maintain and improve our Quality Management System and associated processes to comply with ISO 13485
Ensure compliance with other required standards, such as ISO 62304, 14791, 62366, etc.
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.
What We Are Looking For
Experience in the certification of medical devices, ideally of software solutions
Broad knowledge of norms and standards relevant for medical device development (ISO 13485, 62304, 14971, 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
Experience with agile development processes
Knowledge of regulatory requirements in China and India
Gross salary starting from 3,000€ monthly, negotiable
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
How to apply Interested? Send an email to firstname.lastname@example.org 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…).