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.
This posting is for an existing vacancy.
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