Regulatory & Quality Manager

Floy GmbH; Deutschland; Hybrid; EUR 65.000 - 95.000; Vollzeit

Zusammenfassung

Floy GmbH is seeking a Regulatory Affairs professional in Germany to transform complex requirements into scalable processes that support AI-medical device development and certification. You will collaborate with Product, AI, Engineering, and Marketing to embed quality, regulatory compliance, and clinical value across the product lifecycle.

You will own the ISO 13485 QMS, drive MDR conformity assessments with the Notified Body, and prepare rigorous documentation for AI-enabled devices.

Qualifikationen

• Bachelor's or Master's degree in Life Sciences or related field.
• Proficiency in English and German (written and spoken).
• Experience in Regulatory Affairs for medical devices (EU MDR preferred).
• Strong written communication and clear documentation.
• Analytical, pragmatic and solution-oriented mindset.
• Ability to work independently while collaborating across teams.
• Interest in digital health and AI.

Aufgaben

• 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 regulatory partner for interdisciplinary product teams.
• Support audits, risk management, and continuous improvement activities.

Kenntnisse

English & German

Regulatory Affairs

Written communication

Analytical thinking

Cross-functional collaboration

AI / digital health interest

Ausbildung

Bachelor's or Master's in Life Sciences / Medical Tech / Biomedical Eng / Regulatory Affairs

Jobbeschreibung

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.