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Floy is seeking a Regulatory & Quality Manager to lead regulatory compliance and quality management for AI-powered medical devices. You will own and continuously improve the ISO 13485-certified Quality Management System, lead MDR conformity assessments and interactions with the Notified Body, and prepare technical documentation for innovative medical devices. Working as part of the Medical Excellence team, you will collaborate closely with Product, AI, Engineering, and Marketing to ensure quality, regulatory compliance, and clinical value are integrated throughout the entire product lifecycle.
Key responsibilities include acting as the regulatory partner for interdisciplinary product teams, supporting audits and risk management activities, and driving continuous improvement. You will transform complex regulatory requirements into practical, scalable solutions that enable the development and successful certification of cutting-edge AI medical devices.
The ideal candidate holds a Bachelor's or Master's degree in Life Sciences, Medical Technology, Biomedical Engineering, Regulatory Affairs, or a related field. You must have professional proficiency in both English and German (written and spoken). Experience in Regulatory Affairs for medical devices under EU MDR is essential. You should demonstrate strong written communication skills, analytical thinking, and a pragmatic, solution-oriented mindset. The role requires the ability to work independently while collaborating effectively across interdisciplinary teams, with genuine enthusiasm for digital health, AI, and innovative medical technologies.
Floy offers a flexible, remote-friendly team culture with regular company retreats, autonomy in your work, and fair compensation. The company supports professional growth through regular feedback, weekly 1:1s, and meaningful, challenging work alongside thoughtful, capable colleagues.
