Regulatory Affairs Engineer, Manufacturing Lifecycle
Core
Ensure regulatory compliance and design transfer for medical device manufacturing and distribution.
Role type
Regulatory Affairs Engineer (Manufacturing Lifecycle)
Builds
Manufactured medical devices ready for market release
Domain
Medical Devices / Manufacturing / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design transfer, Good Manufacturing Practice (GMP), manufacturing records management, device release documentation, customs documentation, FDA import requirements, production process validation, ISO 13485, EU MDR, FDA 21 CFR Part 820
Preferred skills
Visual Studio Code, Azure DevOps, AI tools (e.g., Claude), Swedish language
Technologies
ISO 13485, EU MDR, FDA 21 CFR Part 820, Visual Studio Code, Azure DevOps, Claude
Responsibilities
Manage design transfer from engineering to production, maintain regulatory controls for incoming components and equipment calibration, oversee manufacturing and release records, prepare shipment documentation for US and other markets, monitor GMP compliance, collaborate with production teams on-site.
Seniority
Mid-level (3-5 years experience)
