Regulatory Compliance Engineer
Core
Execute tasks under the Quality Management System to ensure product safety, efficacy, reliability, and compliance with regulatory requirements during New Product Development.
Role type
Senior IC regulatory compliance engineer (medical/industrial manufacturing)
Builds
Design History Files, Risk Management reports, verification processes, and production qualification matrices for medical and industrial products.
Domain
Medical devices and industrial manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory compliance, risk management, FMECA, 6M analysis, PPAP, process qualification, blueprint reading, statistical analysis
Preferred skills
statistical process control, new product development, supply chain management
Technologies
Quality Management Systems, PDM, CAD
Responsibilities
Support Core Leadership on NPD projects and mentor other compliance engineers; Lead risk management and coordinate Risk Management Board reviews; Conduct Design for Manufacturing Analysis and support Production Engineers with process qualification (IQ/OQ/PQ); Support Design Engineers in setting up verification test methods and coordinating third-party certification; Ensure compliance with applicable safety standards and regulations.
Seniority
Mid-level, hands-on IC with mentorship responsibilities
