Engineering Compliance and CSV Manager
Core
Ensure medical device software is built, verified, and documented to be compliant, trustworthy, and audit-ready; act as an independent evaluator setting standards for 'done and compliant' work.
Role type
Engineering Compliance and CSV & Process Validation Manager
Builds
Medical device software portfolio ensuring regulatory compliance and validated processes
Domain
Medical devices / Regulated software
Deliverable
production ML models | product features
Required skills
Computer system validation (CSV), Process validation, Risk-based scoping, MDR, ISO 13485, IEC 62304, IEC 82304-1, Software engineering fundamentals, Audit representation, Design change impact assessment
Preferred skills
Medical device industry experience, Pharma/biotech/IVD experience, React, Python, PHP, Go, AWS, Terraform, Kubernetes, ArgoCD
Technologies
React, Python, PHP, Go, AWS, Terraform, Kubernetes, ArgoCD
Responsibilities
Own CSV and process validation processes including procedures, templates, and work instructions; Maintain system inventory and plan/execute validation based on risk; Operate compliance gates in the release flow and sign off releases; Define compliance requirements and traceability in the delivery pipeline; Onboard and train software engineers on compliance requirements; Act as point of contact for audits and technical reviews; Drive resolution of audit findings and deficiencies; Assess engineering impact of design changes.
Seniority
Mid-Senior, hands-on IC
