Regulatory Compliance Lead
Location
georgetown, on
Job Type
Full-time
Category
Management & Operations
Posted
June 13, 2026
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...