Regulatory & Quality Manager

floy.com; Hamburg; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Benefits dieser Stelle

Remote-friendly culture

Regular company retreats

Fair compensation

Zusammenfassung

Floy is seeking a Regulatory Affairs lead to translate complex regulatory requirements into practical, scalable solutions that support AI medical devices throughout the product lifecycle.

You will own ISO 13485 QMS, lead MDR conformity activities with the Notified Body, and prepare technical documentation for AI-powered medical devices.

Join a remote-friendly, interdisciplinary team and help ensure quality, regulatory compliance, and clinical value while driving innovation.

Qualifikationen

• Bachelor's or Master's degree in Life Sciences, Medical Technology, Biomedical Engineering, Regulatory Affairs, or related field.
• Professional proficiency in English and German (written and spoken).
• Experience in Regulatory Affairs for medical devices, ideally under 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 across interdisciplinary teams.
• Enthusiasm for digital health, AI, and innovative medical technologies.

Aufgaben

• 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.

Kenntnisse

Regulatory affairs experience

Written communication

Analytical thinking

Independent yet collaborative

Ambition for digital health/AI

Ausbildung

Bachelor's or Master's in Life Sciences/Regulatory Affairs

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.