Regulatory Compliance Lead for Medical Devices

Excel as a Regulatory Compliance Lead at CPI, focusing on medical X-ray systems and electronic assemblies. Ensure compliance with industry standards and global regulations in this pivotal role.
CPI is seeking an experienced Regulatory Compliance Lead responsible for managing compliance activities for medical X-ray generators and high-voltage power supplies. You will ensure adherence to regulations such as FDA CDRH and ISO standards while coordinating EMC and radiation safety testing. This role entails supporting customers with compliance documentation and ensuring regulatory changes are monitored for impact on products.
Key Responsibilities:
• Lead compliance activities for medical electronic equipment
• Coordinate third-party testing and certification efforts
• Maintain technical files and compliance documentation
• Monitor changes in global regulations affecting products
• Support internal audits and design reviews
Requirements:
• Bachelor’s degree in a rel...