Product Compliance Specialist
Core
Ensure international trade operations and product development comply with complex global regulatory requirements for health, safety, and environmental standards.
Role type
Senior IC product compliance specialist (regulatory & trade)
Builds
Global trade operations and compliant product development workflows for scientific instruments
Domain
Life sciences instrumentation / Global trade compliance / Regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory framework interpretation, trade compliance management, technical standards analysis, audit execution, risk assessment, cross-functional collaboration, process optimization, documentation management, stakeholder guidance
Preferred skills
Functional Safety Engineer certification, CE representative certification, AI tool implementation
Technologies
AI-driven compliance tools, CE Technical Files, EN 61010, EN 60601, Low Voltage Directive, Machinery Regulation, IVD Regulation
Responsibilities
Manage day-to-day import/export activities including classification, screening, licensing, and documentation; Research and interpret current standards to ensure CE, NRTL, and other required compliances; Design and execute comprehensive internal and external testing strategies; Serve as CE representative creating and maintaining technical product documentation; Monitor and implement updates to evolving standards and regulations; Lead compliance coordination efforts across multiple global sites
Seniority
Mid-level, hands-on IC