Regulatory Compliance Lead

Role Overview

Regulatory Compliance Lead responsible for ensuring global regulatory and standards compliance for medical X-ray generator systems, high-voltage power supplies, RF products, and related electronic assemblies.

Responsibilities

• Lead regulatory compliance activities for medical X-ray generators, high-voltage power supplies, RF products, and related electronic assemblies.
• Ensure compliance with FDA CDRH Radiation Product Requirements, IEC 60601, IEC 62368-1, ISO 13485, ISO 9001, and ISO 14971.
• Coordinate EMC, electrical safety, environmental, and radiation safety testing activities.
• Maintain technical files, declarations of conformity, test reports, and compliance documentation.
• Support customer regulatory requirements and provide documentation for customer submissions and market approvals.
• Monitor changes in global regulations and standards and assess impacts on products.
• Supp...