Senior Regulatory Compliance Engineer

Communications & Power Industries (CPI); Georgetown; On-site; CAD 90,000 - 130,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Career development

Job summary

Communications & Power Industries (CPI) seeks a Senior Regulatory Compliance Engineer to lead global regulatory and standards activities for medical X-ray generator systems, high-voltage power supplies, RF products, and related assemblies. You will ensure safety, EMC, radiation, and environmental compliance across the product lifecycle.

You will coordinate testing, maintain technical files, support customer submissions, and monitor regulatory changes while collaborating with cross-functional

Qualifications

• Bachelor’s degree in electrical-related engineering.
• 7+ years in regulatory compliance, product safety, EMC, or related field.
• Experience with medical electrical equipment or high-voltage systems.
• Knowledge of IEC 60601, IEC 62368-1, ISO 13485, ISO 9001, ISO 14971.
• Experience coordinating third‑party testing and certification.
• Strong technical writing and cross-functional collaboration.

Responsibilities

• Lead regulatory compliance activities for medical X-ray generators and related assemblies.
• Plan and coordinate EMC, electrical safety, environmental, and radiation testing.
• Prepare and maintain technical files, declarations of conformity, and certificates.
• Support customer submissions and market approvals.
• Monitor global regulatory changes and assess impact.
• Provide input during design reviews and risk management.
• Assist internal audits and regulatory audits.
• Manage relationships with testing labs and certification bodies.

Skills

Regulatory compliance

Product safety

EMC knowledge

Technical writing

Project management

Leadership

CGP travel ability

Education

Bachelor’s degree in Electrical/Electronics/Biomedical Engineering

Job description

Senior Regulatory Compliance Engineer

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 programs, career development, generous retirement savings plan with company match and more!

Who We Are

We value the unique and diverse skills, qualities, and backgrounds that each employee brings to CPI, and we respect each employee as an integral member of our growing team. CPI is committed to providing equal employment opportunities for all current and prospective employees, as well as to promoting a culture of inclusion and respect for everyone. We celebrate the innovation that diversity creates in the work environment, and we recognize that each employee brings their own unique capabilities, experiences, and perspectives to the organization. It is this variety that adds value to our teams, as well as to our stakeholders. We welcome and encourage applicants to reach their full potential with us.

CPI is proud to be an Equal Opportunity and Affi

This posting is for an existing vacancy.