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Full-time
bachelor degree, postgraduate degree
Flexible work culture, Remote-friendly, Company retreats, Fair compensation, Professional growth support, Regular feedback
Posted 8h ago
~40 hrs/week
Remote in Hamburg, Germany
Responsibilities
You will manage the ISO 13485-certified Quality Management System and lead MDR conformity assessments for AI-powered medical devices. Additionally, you will act as a regulatory partner for interdisciplinary teams to ensure compliance throughout the product lifecycle.
Requirements
Candidates must hold a Bachelor's or Master's degree in Life Sciences, Medical Technology, or a related field. Proficiency in English and German, along with experience in Regulatory Affairs for medical devices, is required.
Full job description
Your mission
At Floy, Regulatory & Quality is a key enabler of innovation. Your mission is to transform complex regulatory requirements into practical, scalable solutions that support the development and successful certification of AI medical devices. As part of the Medical Excellence team, you will collaborate closely with Product, AI, Engineering, and Marketing to ensure that quality, regulatory compliance, and clinical value are integrated throughout the entire product lifecycle.
Your responsibilities
Own and continuously improve our ISO 13485-certified Quality Management System.
Lead MDR conformity assessments and interactions with our Notified Body.
Prepare technical documentation for AI-powered medical devices.
Act as the regulatory partner for our interdisciplinary product teams.
Support audits, risk management, and continuous improvement activities.
What are we looking for?
Bachelor's or Master's degree in Life Sciences, Medical Technology, Biomedical Engineering, Regulatory Affairs, or a related field.
Professional proficiency in English and German (written and spoken).
Experience in Regulatory Affairs for medical devices, ideally under the EU MDR.
Strong written communication skills and the ability to prepare clear, structured documentation.
Analytical thinking and a pragmatic, solution-oriented mindset.
Ability to work independently while collaborating effectively across interdisciplinary teams.
Enthusiasm for digital health, AI, and innovative medical technologies.
Why us
Pioneer medical AI to maximize human health. Become part of an ambitious team valuing individuals, dedication and a joyful work experience. Solve novel challenges with life-saving implications.
We support your growth through regular feedback, weekly 1:1s, and meaningful, challenging work.
We offer autonomy, flexibility, and the chance to work alongside thoughtful, capable colleagues.
We have a flexible, remote-friendly team culture, regular company retreats, and fair compensation.
About us
Floy is on a mission to build the infrastructure for personalized health. Today, our AI products help radiologists to detect typically overlooked diseases. We envision a future where everybody can access annual holistic health assessments to prevent diseases through early detection.
Floy was founded in June 2021 and raised 12m€ total funding from Europe’s leading investors. Over the last months, the team grew to 60 exceptional people. Our pace only accelerates from here.
Maximizing the diagnostic value of routine imaging with artificial intelligence.
Industry
Software Development
Company size
51-200 employees
Founded
2021
Headquarters
Munich, Bavaria
LinkedIn followers
19,824
Total funding
$13M
Healthcare generates 30% of the world’s data, yet 97% of it remains unused. Floy's certified AI software analyzes every radiological scan beyond its original indication, uncovering clinically relevant findings that might otherwise go unnoticed. By turning routine imaging into a tool for opportunistic risk detection, Floy empowers radiologists to make faster, broader, and more informed decisions - creating real value for patients and providers alike.
Since launching in 2021, Floy has secured more than €12 million in funding and expanded rapidly. Today, over 250 radiology sites across Germany and Europe rely on Floy every day. We bring together leading minds in technology, medicine, and science with one clear mission:
Maximize. Human. Health.
Offices: Ludwigstraße 9, Munich, Bavaria 80539, DE · Ludwigstraße 9, Munich, Bavaria 80539, DE
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