Regulatory Compliance Engineer
Core
Ensure product safety, efficacy, reliability, and compliance with regulatory requirements for New Product Development projects.
Role type
Senior IC regulatory compliance engineer
Builds
Design History Files, Risk Management reports, verification processes, and production qualification matrices
Domain
Medical device manufacturing and industrial engineering
Required skills
regulatory compliance, risk management, FMECA, 6M analysis, PPAP, statistical analysis, blueprint reading, process validation
Preferred skills
new product development, quality management, supply chain management, 3rd party certification coordination
Responsibilities
Support Core Leadership on NPD projects, create Design History Files, lead risk management reviews, conduct FMECA and 6M analysis, support production process qualification, design verification procedures, coordinate 3rd party testing, support design transfer to operations
Seniority
Mid-level, hands-on IC