Senior Regulatory Compliance Engineer

Socket.dev; Georgetown; On-site; CAD 166,000 - 208,000; Full time

Job summary

Communications & Power Industries seeks a Senior Regulatory Compliance Engineer to ensure global regulatory and standards compliance for medical X-ray generator systems, high-voltage power supplies, RF products, and related electronic assemblies. The role serves as a senior technical resource for product safety, EMC, radiation safety, environmental compliance, and quality management.

You will lead regulatory activities, coordinate testing and certification, maintain technical files, and support

Qualifications

• Bachelor’s degree in Electrical/ Electronics/ Biomedical Engineering or related field.
• 7+ years in regulatory compliance, product safety, EMC, or certification.
• Experience with medical electrical equipment, power electronics, HV systems, RF products.
• Strong knowledge of IEC 60601, IEC 62368-1, ISO 13485, ISO 9001, ISO 14971 and environmental requirements.
• Ability to interpret standards and apply regulatory requirements through the product lifecycle.
• Experience coordinating third-party testing and certification activities.
• Strong technical writing, communication, and project management skills.
• Ability to work independently and lead cross-functional compliance initiatives.
• Ability to meet CGP requirements and travel occasionally.

Responsibilities

• Lead regulatory compliance activities for medical X-ray generators, HV power supplies, RF products, and related assemblies.
• Ensure products meet FDA CDRH radiation requirements, IEC 60601, IEC 62368-1, ISO 13485/9001/14971.
• Plan and coordinate EMC, electrical safety, environmental, and radiation safety testing and certification.
• Prepare and maintain technical files, declarations of conformity, test reports, certificates, and other docs.
• Support customer regulatory submissions and market approvals.
• Monitor changes to global regulations and assess impact on CPI products.
• Provide input during design reviews, risk management, V&V, and change assessments.
• Support internal, customer, certification, and regulatory audits.
• Manage relationships with labs, certification bodies, and regulatory consultants.
• Ensure compliance with RoHS, REACH, WEEE, PFAS, Conflict Minerals, and environmental requirements.
• Provide regulatory guidance to Engineering, Quality, Manufacturing, Product Management, and cross-functional teams.
• Identify compliance risks and recommend corrective actions.
• Perform other duties as required.

Skills

Regulatory compliance

Technical writing

Project management

Cross-functional collaboration

Independent work

Education

Bachelor’s degree in Electrical/ Electronics/ Biomedical Engineering

Job 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 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 Aff®ive Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability or other applicable legally protected characteristics.

This posting is for an existing vacancy.