Senior Compliance Engineer for Medical Devices
3 days ago
Halton Hills, Ontario, Canada
Communications & Power Industries (CPI)
Full-time
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Advance your career as a Senior Regulatory Compliance Engineer with Communications & Power Industries. Ensure global compliance for medical X-ray systems and other electronic products in a collaborative environment.
In this role, you will focus on regulatory compliance and standards for medical devices and power systems. You'll lead compliance efforts with FDA, IEC, ISO standards while preparing key documentation, overseeing testing, and guiding design reviews. Your leadership will support regulatory audits and manage external relationships to ensure product safety.
Key Responsibilities
• Lead regulatory compliance for medical X-ray generators
• Ensure adherence to FDA, IEC, and ISO standards
• Plan and conduct EMC and safety testing
• Prepare technical documentation for product compliance
• Support customer submissions and market approvals
Requirements:
• Bachelor's in a related technical discipline
• 7+ years in regulatory compliance or safety
• Experience with medical and electronic assemblies
• Strong understanding of safety and EMC standards
• Proven project management and communication skills Utilize your expertise in regulatory compliance to enhance product quality and safety at CPI.
Key Responsibilities
• Lead regulatory compliance for medical X-ray generators
• Ensure adherence to FDA, IEC, and ISO standards
• Plan and conduct EMC and safety testing
• Prepare technical documentation for product compliance
• Support customer submissions and market approvals
Requirements:
• Bachelor's in a related technical discipline
• 7+ years in regulatory compliance or safety
• Experience with medical and electronic assemblies
• Strong understanding of safety and EMC standards
• Proven project management and communication skills Utilize your expertise in regulatory compliance to enhance product quality and safety at CPI.