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.

Support design reviews, risk man...