Engineering Compliance and CSV Manager

Engineering Compliance Manager and CSV & Process Validation Manager for the AMBOSS medical device team. You'll work closely with engineering as an independent evaluator, setting the standard for what "done and compliant" means across our medical device software, ensuring our product is built, verified, and documented in a way that's compliant, trustworthy, and audit-ready.

What you'll do

• Own the computer system validation and process validation processes for the AMBOSS medical device portfolio — procedures, templates and work instructions — keeping them aligned with MDR and ISO 13485.
• Maintain the inventory of systems in scope and decide, risk-based, which need validation and to what depth; plan, execute and document that validation and keep systems in a validated state as they change.
• Concentrate validation effort where the evidence is produced — test management, defect tracking, build/release tooling and automated pipeline steps.
• Own the resulting evidence and represent it directly to auditors and regulators; raise, document and own validation deviations and the associated CAPAs through to resolution.
• Own compliant execution of the software lifecycle — requirements, design, implementation, verification, release — against IEC 62304 and IEC 82304-1.
• Define the compliance requirements and gates in our delivery pipeline and partner with engineering to implement them.
• Operate the compliance gate in the release flow; sign off each release as a required gate.
• Onboard and train software engineers on compliance requirements and how to work within them day-to-day.

What you'll need

• Knowledge of medical devices or another regulated industry (pharma, biotech, IVD), with experience in or eagerness to learn computer system validation and/or process validation.
• Working knowledge of MDR, ISO 13485, IEC 62304 and IEC 82304-1 as they apply to software.
• Familiarity with software engineering and depth in our stack (React, Python, PHP, Go; AWS, Terraform, Kubernetes, ArgoCD) to review pipelines, tests and release processes with engineers as a peer.
• Experience representing validation documentation and rationale to auditors and inspectors.
• Experience assessing the engineering/technical impact of Design Changes within a regulated development process.
• Excellent written and spoken English.

Nice to have

• Experience with computer system validation and/or process validation, including risk-based scoping of validation effort.

What they offer

• Comprehensive employee benefits package supporting financial, physical, and mental health and work-life harmony.