Regulatory & Quality Manager

This is a fully remote position, open to applicants in Germany.

📋 Description

• Take ownership of and enhance Floy's ISO 13485-certified Quality Management System.

• Lead conformity assessments for MDR and manage relationships with the Notified Body.

• Develop technical documentation for AI-driven medical devices.

• Serve as the regulatory liaison for cross-functional product teams.

• Assist with audits, risk management, and initiatives for continuous improvement.

• Collaborate with Product, AI, Engineering, and Marketing teams to embed 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 discipline.

• Professional proficiency in both English and German, in written and spoken forms.

• Experience in Regulatory Affairs for medical devices, preferably under the EU MDR.

• Exceptional written communication skills with the ability to produce clear and structured documentation.

• Strong analytical skills and a pragmatic, solution-focused approach.

• Capacity to work autonomously while effectively collaborating with interdisciplinary teams.

• Passion for digital health, AI, and cutting-edge medical technologies.

🏝️ Benefits

• Regular feedback.

• Weekly one-on-one meetings.

• Engaging and challenging work.

• Autonomy in your role.

• Flexibility in work arrangements.

• A remote-friendly team culture.

• Frequent company retreats.

• Competitive compensation.