Engineering Compliance and CSV Manager

Onsite Berlin

pythonreactawskubernetesgoterraform research & development

arbeitnow

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Job description

You will manage compliance and validation processes for medical device software at AMBOSS in Berlin. This role involves ensuring that products meet regulatory standards and maintaining documentation for audits.

Details

Berlin, work from office
Experience in medical devices or regulated industries preferred
Skills: python, react, aws, kubernetes, go, terraform

The work

Own computer system validation and process validation for medical device portfolio
Ensure compliant execution of the software lifecycle against IEC 62304 and IEC 82304-1
Act as the point of contact for audits and technical reviews
Onboard and train software engineers on compliance requirements