Head of Regulatory Affairs

Head of Regulatory Affairs - 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 developing AI-based medical device software that is certified according to the MDR and are striving for international market placement of our products.

Currently we have the unique opportunity to join us as Head of Regulatory Affairs where 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 our target markets. You will have the opportunity to work across teams to support product development as well as marketing and sales teams in their tasks.

As a Head of Regulatory Affairs, you will:

• Own / ensure regulatory compliance of our devices, including risk management, post-market surveillance, clinical evaluation, market clearance, product labeling, product registration
• Define regulatory strategies for new products to be placed in applicable markets
• Own & maintain corresponding processes within our ISO 13485-certified Quality Management System
• Support our product development team in the development of AI-based image analysis solutions
• Support our marketing team in creating regulatory-compliant sales materials

Requirements

What we are looking for:

• Experience with regulating / clearing Software as a Medical Device under MDR
• Experience with corresponding applicable standards and norms (ISO 13485, ISO 14971, IEC 62304, IEC 62366, ISO 27001, … )
• Experience with regulating / clearing AI-based image analysis solutions within radiology
• Experience with market clearance in the US
• Background in IT, Medical Imaging or any another relevant scientific discipline
• Ability to work independently
• Structured work style and high level of self-motivation
• Strong belief in growing together as a team and having empathy for each other
• Experience with leading & growing teams
• Work permit in EU
• Open to travel on a quarterly/monthly basis
• Fluency in English

Bonus Skills:

• Experience with ensuring regulatory compliance of agile development processes
• Experience with MDSAP
• German, Dutch or any Scandinavian language a plus

Benefits

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:

• 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

Founded in 2016, we are one of the leading AI medical imaging startups, having grown to 35 people. To date, we have raised over €15 million from VCs and EU grants and work together with renown customers across Europe.

Join an award-winning team:

• EIC Accelerator Equity Program 2023
• GE HealthCare Canada Accelerator 2022
• Winner, European Radiology Most Downloaded Article 2021
• WKO Born Global Champions 2021
• EIC Acceleratory Grant 2020
• Top AI30 (2020) - Forbes DACH
• Best Healthtech Startup 2019 (Austria) - Central European Startup Awards
• Best Pitch 2019 (Healthcare) - Pioneers Festival
• Philips HealthWorks 2018 - Chosen as one of 19 participants out of 700+ applications
• Digital Innovation Award 2017 - Austrian Federal Ministry of Education, Science and Research
• Most Promising Startup 2016 - BCS Search Industry
• Science & Business Award 2016 - Rudolf Sallinger Fonds

We are an equal opportunities employer and value diversity!

Salary Negotiable Based On Experience And Know-how

How to apply:

Interested?

Send us your CV and your motivational letter with max 1500 characters (: half a page), letting us know why you would like to join contextflow and how you can best contribute. You may provide links or attachments with information about yourself (LinkedIN, Xing, website, github…)

Kindly note that reference letters and contacts may be requested as part of the recruitment process.

We look forward to receiving your application!