Regulatory & Quality Manager

Floy; Deutschland; Hybrid; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Floy is seeking a Regulatory & Quality professional to transform complex regulatory requirements into scalable solutions for AI medical devices. You will join the Medical Excellence team and collaborate with Product, AI, Engineering, and Marketing to ensure quality, regulatory compliance, and clinical value throughout the product lifecycle.

You will own the ISO 13485-certified QMS, lead MDR conformity assessments, and prepare documentation for AI-powered medical devices, working

Qualifikationen

• Proven experience in Regulatory Affairs for medical devices (EU MDR preferred).
• Strong written communication skills and ability to prepare clear documentation.
• Analytical thinker with pragmatic, solution-oriented mindset.
• Ability to work independently and collaborate across interdisciplinary teams.
• Interest in digital health, AI, and innovative medical technology.

Aufgaben

• Own and continuously improve ISO 13485-certified QMS.
• Lead MDR conformity assessments and interactions with Notified Body.
• Prepare technical documentation for AI-powered medical devices.
• Act as regulatory partner for interdisciplinary product teams.
• Support audits, risk management, and continuous improvement.

Kenntnisse

English proficiency

German proficiency

Regulatory Affairs

Written communication

Analytical thinking

Cross-functional collaboration

Digital health / AI interest

Ausbildung

Bachelor's degree in Life Sciences/related field

Master's degree in Life Sciences/related field

Jobbeschreibung

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.
• 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.

Why us

Pioneer medical AI to maximize human health. Become part of an ambitious team valuing individuals, dedication and a joyful work experience. Solve novel challenges with life-saving implications.

• We support your growth through regular feedback, weekly 1:1s, and meaningful, challenging work.
• We offer autonomy, flexibility, and the chance to work alongside thoughtful, capable colleagues.
• We have a flexible, remote-friendly team culture, regular company retreats, and fair compensation.