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Join Communications & Power Industries as a Senior Regulatory Compliance Engineer, focusing on medical X-ray generators and related technologies. Apply your expertise in compliance to ensure product safety and regulatory adherence.
As a key player, you will manage and execute regulatory compliance activities for medical equipment, ensuring products meet CDRH and IEC standards. This role involves preparing essential compliance documents, conducting safety tests, and performing risk assessments to safeguard products in the market. Your teamwork will be crucial in audits and assessing industry regulations.
Key Responsibilities:
• Lead compliance activities for X-ray generator systems
• Ensure conformity with FDA and international standards
• Coordinate radiation safety and environmental testing
• Maintain technical files and compliance reports
• Engage with certification and regulatory bodies
Requirements:
• Degree in Electrical or Biomedical Engineering
• 7+ years in compliance or certification
• Familiarity with medical power electronics
• Strong technical writing and leadership skills
• Must meet Canadian Controlled Goods Program requirements
Bring your regulatory expertise to CPI to ensure the highest product safety and quality standards.
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