Engineering Compliance and CSV Manager

About the role

AMBOSS is seeking an Engineering Compliance and CSV & Process Validation Manager to join our medical device team. This role ensures that our medical device software is built, verified, and documented in a compliant, trustworthy, and audit-ready manner. You will act as an independent evaluator, setting standards for compliance and validation across our product portfolio.

Responsibilities

• Own the computer system validation and process validation processes for the AMBOSS medical device portfolio.
• Maintain the inventory of systems in scope and plan, execute, and document validation efforts.
• Represent validation evidence directly to auditors and regulators and manage validation deviations and CAPAs.
• Own the compliant execution of the software lifecycle against IEC 62304 and IEC 82304-1 standards.
• Define compliance requirements and gates in the delivery pipeline and operate the compliance gate in the release flow.
• Onboard and train software engineers on compliance requirements and act as the point of contact for audits and technical reviews.

Required skills

• MDR
• ISO 13485
• IEC 62304
• IEC 82304-1
• Software engineering
• Regulatory compliance

Nice to have

• Computer system validation
• Process validation
• React
• Python
• PHP
• Go
• AWS
• Terraform
• Kubernetes
• ArgoCD

Qualifications

• Knowledge of medical devices or another regulated industry (pharma, biotech, IVD)
• Experience representing validation documentation and rationale to auditors and inspectors
• Experience assessing the engineering/technical impact of Design Changes within a regulated development process

Benefits

• Financial health support
• Physical health support
• Mental health support

About the Company

AMBOSS is a dynamic learning and clinical decision support tool committed to empowering physicians globally to deliver optimal care. Since 2012, the company has harnessed cutting-edge technology to transform the way physicians acquire and apply scientific knowledge.