Regulatory & Quality Manager

Floy

14h • Remote

About The Position

At Floy, Regulatory & Quality is a key enabler of innovation. This role's 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, the individual 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.

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 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.

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.

Benefits

• Regular feedback
• Weekly 1:1s
• Meaningful, challenging work
• Autonomy
• Flexibility
• Chance to work alongside thoughtful, capable colleagues
• Flexible, remote-friendly team culture
• Regular company retreats
• Fair compensation

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level