Engineering Compliance Manager and CSV & Process Validation Manager

📋 Description

• Own CSV and process validation for AMBOSS medical device portfolio
• Ensure MDR/ISO 13485 compliance in procedures and templates
• Manage validation breadth based on risk and system changes
• Provide evidence to auditors/regulators and handle CAPAs
• Oversee software lifecycle compliance from requirements to release
• Collaborate with engineering to implement compliance gates

🎯 Requirements

• Knowledge of MDR, ISO 13485, IEC 62304, IEC 82304-1
• Familiarity with React, Python, PHP, Go; AWS, Terraform, Kubernetes, ArgoCD
• Experience presenting validation docs to auditors/inspectors
• Excellent written and spoken English

🎁 Benefits

• Benefits package supporting financial, physical, and mental health
• Inclusive, supportive work environment
• Encouragement to apply even if not all points are met