Regulatory Affairs Manager
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 EN ISO 13485:2016 certified medical device company and are currently expanding our team. Thus, we have the unique opportunity to join us as a Regulatory Affairs Manager. We are developing AI-based medical device software that is certified according to the MDR and are striving for international market placement of our products. You will have the chance to play a key role during development of medical device software products and will be responsible for the expansion of our products in the US, Canada and other exciting markets. You will be working alongside motivated team colleagues that are eager to expand their knowledge and to share their experiences. Also you will have the opportunity to work across teams to support the product development as well as marketing and sales team in their tasks.
As a Regulatory Affairs Manager, you will
- be responsible for market placement of AI medical device software products in the US
- plan strategies for market placement outside the EU
- support the regulatory affairs team in complying to EU regulations
- be part of internal and external MDR and ISO audits
- plan and conduct clinical testing strategies for US market placement
- support product development in the development of AI medical device software
What you can expect
You will be part of an interdisciplinary team, characterized by close collaboration and sharing of knowledge across boundaries of individual fields. We are focused on developing cutting-edge deep learning techniques that serve the rapidly-advancing needs of precision medicine and clinical practice. We place a 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.
Moreover, you will
You will be part of an interdisciplinary team, characterized by close collaboration and sharing of knowledge across boundaries of individual fields. We are focused on developing cutting-edge deep learning techniques that serve the rapidly-advancing needs of precision medicine and clinical practice. We place a 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.
- 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, remote work possible
- Enjoy other perks such as company retreats, public transport tickets, myclubs membership, etc.
What We Are Looking For
- Ability to work independently
- Self-motivated to perform tasks and complete work packages
- Experience with FDA clearance and US reader studies
- 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
- Open to travel on a quarterly/monthly basis
Bonus Skills
- Experience with agile development processes
- Experience with clinical evaluation and risk management procedure for medical devices
Gross salary starting from
56.000€, 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…).