Regulatory & Quality Manager
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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.
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