Regulatory & Quality Manager

🕒 August 11

🇩🇪 Germany – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 38%

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Floy

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2021

🏥 Healthcare

💼 Consulting

🤖 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.

📋 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

🎯 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

🏖️ 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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