✨ The Role in One Sentence

We are seeking a Senior Regulatory Affairs & Quality Manager to oversee regulatory compliance and quality management for our software products.

📋 What You'll Likely Do

• 30%: Manage and develop technical documentation in compliance with international standards.

• 30%: Lead audit preparations and certifications, such as ISO 13485 or ISO 27001.

• 40%: Ensure products meet DiGA reimbursement status in Germany and maintain cybersecurity strategies.

🧑‍💻 Profiles Doing This Job

• High Priority: Extensive experience in regulatory affairs and quality management for medical devices.

• High Priority: Strong knowledge of MDR, ISO 13485, ISO 14971, IEC 62304, ISO 27001.

• High Priority: Experience with digital health applications (DiGA) and regulatory submissions.

📈 How This Role Will Look on Your CV

• Managed regulatory affairs and quality management in a dynamic, agile environment.