Regulatory Compliance Specialist

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 Specialist responsible for ensuring global regulatory compliance of medical X-ray generator systems and associated high-voltage/RF products. This role leads regulatory strategy, product submissions, radiation safety compliance, EMC certification activities, and global market approvals throughout the product lifecycle.

YOU WILL BE ACCOUNTABLE FOR/TO:

• Prepare and manage regulatory submissions, including CDRH Radiation Product registrations, annual reports and radiological health submission (21 CFR 1020), Health Canada and CE Technical Documentation under EU MDR.
• Ensure compliance with medical device regulations including FDA QSMR (21 CFR Part 820), EU MDR 2017/745 and Canada SOR/98-282.
• Ensure compliance with ISO 13485, ISO 9001, ISO 14971, IEC 60601 series standards (medical device safety and performance including X-ray generator collateral standards), IEC 62368-1 (information and communication technology equipment – safety requirements).
• Familiarity with EU Directives such as the Low Voltage Directive, EMC Directive, Radio Equipment Directive.
• Lead EMC compliance activities, including test planning, coordination with third-party laboratories, and review of test reports.
• Maintain relationships with Regulatory Authorities and service providers (Authorised Representatives, Notified Bodies, Registrars).
• Support Quality Assurance during audits.
• Support engineering teams during design reviews, risk management activities, verification & validation, and regulatory impact assessments for product changes.
• Maintain Technical Files, Design Dossiers, Declarations of Conformity, and regulatory documentation throughout the product lifecycle.
• Monitor global regulatory changes and assess their impact on existing and new products.
• Ensure environmental and material compliance, including RoHS, REACH, WEEE, PFAS, and conflict minerals requirements.
• Conduct regulatory research and provide guidance on evolving standards and industry trends.
• Other duties as required.

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

• Bachelor’s degree in electrical engineering or a related technical field (equivalent experience will be considered).
• 5+ years of regulatory affairs experience in medical electrical devices or high-voltage/RF systems.
• Strong working knowledge of:
  • EU, FDA, Health Canada medical device regulations
  • Medical Device and Information Technology safety standards
  • EMC compliance standards
  • Environmental and material compliance regulations
• Experience preparing regulatory submissions and maintaining technical documentation.
• Strong technical writing and documentation skills.
• Excellent communication skills with the ability to work cross-functionally and independently.
• Experience working in a regulated assembly and test environment is preferred.
• Must meet all CGP & ITAR requirements
• Limited travel to US may be required. 

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 Affirmative 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. 

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