Regulatory Compliance Lead

Role Overview

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.

• 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.

• Bachelor’s degree in Electrical Engineering, Electronics Engineering, Biomedical Engineering, or a 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.
• Limited travel to the United States and certification laboratories may be required.

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!

CPI is committed to providing equal employment opportunities for all current and prospective employees, and to promoting a culture of inclusion and respect for everyone. 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.