Senior Regulatory Compliance Engineer

Description

We are seeking a Senior Regulatory Compliance Engineer 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 position serves as a senior technical resource for product safety, electromagnetic compatibility (EMC), radiation safety, environmental compliance, and quality management systems while supporting customer and market requirements.

YOU WILL BE ACCOUNTABLE FOR/TO:

• Lead regulatory compliance activities for medical X-ray generators, high-voltage power supplies, RF products, and related electronic assemblies.
• Ensure products comply with applicable FDA Center for Devices and Radiological Health (CDRH) radiation product requirements, IEC 60601, IEC 62368-1, ISO 13485, ISO 9001, and ISO 14971 requirements.
• Plan and coordinate EMC, electrical safety, environmental, and radiation safety testing and certification activities.
• Prepare and maintain technical files, declarations of conformity, test reports, certificates, and other compliance documentation.
• Support customer regulatory requirements by providing documentation for customer submissions, certifications, and market approvals.
• Monitor changes to global regulations and industry standards and assess their potential impact on CPI products.
• Provide regulatory and compliance input during design reviews, risk management activities, verification and validation, and product change assessments.
• Support internal, customer, certification, and regulatory audits.
• Manage relationships with third-party testing laboratories, certification bodies, and regulatory consultants.
• Ensure compliance with applicable RoHS, REACH, WEEE, PFAS, Conflict Minerals, and other environmental requirements.
• Provide technical compliance guidance to Engineering, Quality, Manufacturing, Product Management, and other cross-functional teams.
• Identify compliance risks and recommend appropriate corrective or preventive actions.
• Perform other duties as required.

YOU ARE THE RIGHT PERSON FOR THIS JOB IF YOU HAVE:

• A bachelor’s degree in Electrical Engineering, Electronics Engineering, Biomedical Engineering, or a related technical discipline.
• Seven or more years of experience in regulatory compliance, product safety, EMC, certification, or a related technical function.
• Experience with medical electrical equipment, power electronics, high-voltage systems, RF products, or related electronic assemblies.
• Strong knowledge of IEC 60601, IEC 62368-1, ISO 13485, ISO 9001, ISO 14971, applicable EMC standards, and environmental compliance requirements.
• Experience interpreting technical standards and applying regulatory requirements throughout the product lifecycle.
• Experience coordinating third-party testing and certification activities.
• Strong technical writing, communication, problem-solving, and project management skills.
• The ability to work independently, provide technical leadership, and lead cross-functional compliance initiatives.
• The ability to meet the requirements of the Canadian Controlled Goods Program (CGP).
• The ability to travel occasionally to the United States and certification laboratories.

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.

WHAT WE OFFER:

Whether you are a seasoned professional or just embarking on your career, CPI is an ideal place to expand your knowledge and expertise. We cultivate a healthy, dynamic, and team-oriented environment that empowers our employees to develop, create and deliver innovative, reliable technology solutions to power, connect, protect, and support a better tomorrow.

We offer our employees an attractive compensation package with competitive salaries and comprehensive benefits, including health and wellness p