✨ The Role in One Sentence

We are looking for an ambitious and responsible Senior Quality & Regulatory Affairs Manager to drive projects and bring regulatory-compliant digital health solutions to market.

📋 What You'll Likely Do

• 30%: Ensure products comply with legal regulations, including creating, submitting, and maintaining required legal documents.

• 30%: Implement new legal requirements in the quality management system.

• 40%: Evaluate and improve existing processes and documents, and conduct audits.

🧑‍💻 Profiles Doing This Job

• High Priority: Degree in Engineering, Medical Technology, Life Sciences, or similar.

• High Priority: Experience with MDR/MDD and standards like ISO 13485, ISO 27001, IEC 62304, ISO 14971, IEC 62366.

• High Priority: Excellent communication skills in German and English.

📈 How This Role Will Look on Your CV

• Led quality and regulatory affairs in a digital health venture.