Floy
51 - 200 employees
Founded 2021
đĽ Healthcare
đź Consulting
đ¤ Artificial Intelligence
Healthcare ⢠Consulting ⢠Artificial Intelligence
Floy is a Munich-based technology company that focuses on improving health outcomes by integrating human and artificial intelligence. Their offerings include a comprehensive health assessment service that provides personalized insights into individual health risks, emphasizing preventative care by analyzing medical histories. Floy also features FloyRadiology, a service that utilizes certified AI to assist radiologists in identifying difficult-to-diagnose abnormalities in radiological images, thereby enhancing diagnostic accuracy and facilitating early intervention.
Regulatory & Quality Manager
Job not on LinkedIn
đĽ 29 minutes ago
đŁď¸đŠđŞ German Required
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Floy
51 - 200 employees
Founded 2021
đĽ Healthcare
đź Consulting
đ¤ Artificial Intelligence
Healthcare ⢠Consulting ⢠Artificial Intelligence
Floy is a Munich-based technology company that focuses on improving health outcomes by integrating human and artificial intelligence. Their offerings include a comprehensive health assessment service that provides personalized insights into individual health risks, emphasizing preventative care by analyzing medical histories. Floy also features FloyRadiology, a service that utilizes certified AI to assist radiologists in identifying difficult-to-diagnose abnormalities in radiological images, thereby enhancing diagnostic accuracy and facilitating early intervention.
đ Description
⢠Own and continuously improve Floy's ISO 13485-certified Quality Management System ⢠Lead MDR conformity assessments and interactions with the Notified Body ⢠Prepare technical documentation for AI-powered medical devices ⢠Act as the regulatory partner for interdisciplinary product teams ⢠Support audits, risk management, and continuous improvement activities ⢠Collaborate with Product, AI, Engineering, and Marketing to integrate quality, regulatory compliance, and clinical value throughout the product lifecycle
đŻ Requirements
⢠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 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
đď¸ Benefits
⢠Regular feedback ⢠Weekly 1:1s ⢠Meaningful, challenging work ⢠Autonomy ⢠Flexibility ⢠Flexible, remote-friendly team culture ⢠Regular company retreats ⢠Fair compensation
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