Regulatory Compliance Lead

Communications & Power Industries (CPI)•Halton Hills, ON

2d•Remote

About The Position

Shaping the future through innovation and discovery! With a history spanning more than seven decades, Communications & Power Industries’ thousands of products have impacted people’s lives in numerous unseen ways every day. Our highly engineered products serve as the backbone of modern-day commercial and military communications systems, assist in diagnosing medical conditions, empower scientific discoveries and space exploration, and much more. We are seeking a 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. This role leads compliance activities related to product safety, EMC, radiation safety, environmental regulations, and quality management systems while supporting customer and market requirements.

Requirements

Bachelor’s degree in Electrical Engineering, Electronics Engineering, Biomedical Engineering, or related technical discipline.
7+ years of experience in regulatory compliance, product safety, EMC, or related functions.
Experience with medical electrical equipment, power electronics, high-voltage systems, or RF products.
Strong knowledge of IEC 60601, IEC 62368-1, ISO 13485, ISO 9001, ISO 14971, EMC standards, and environmental compliance regulations.
Experience coordinating third-party testing and certification activities.
Strong technical writing, communication, and project management skills.
Ability to work independently and lead cross-functional initiatives.
Must be able to meet CGP requirements

Nice To Haves

Limited travel to the United States and certification laboratories may be required.

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 management, verification, validation, and product change assessments.
Support internal, customer, and external audits.
Manage relationships with testing laboratories, certification bodies, and consultants.
Ensure compliance with RoHS, REACH, WEEE, PFAS, and Conflict Minerals requirements.
Provide compliance guidance to Engineering, Quality, Manufacturing, and Product Management teams.
Other duties as required.