Regulatory Compliance Engineer For Medical X-Ray Systems (Puslinch)

Regulatory Compliance Engineer For Medical X-Ray Systems (Puslinch)

25 Sep
|
Communications & Power Industries (CPI)
|
Puslinch

25 Sep

Communications & Power Industries (CPI)

Puslinch

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 systemsEnsure conformity with FDA and international standardsCoordinate radiation safety and environmental testingMaintain technical files and compliance reportsEngage with certification and regulatory bodiesRequirements:Degree in Electrical or Biomedical Engineering7+ years in compliance or certificationFamiliarity with medical power electronicsStrong technical writing and leadership skillsMust meet Canadian Controlled Goods Program requirementsBring your regulatory expertise to CPI to ensure the highest product safety and quality standards.

📌 Regulatory Compliance Engineer For Medical X-Ray Systems (Puslinch)
🏢 Communications & Power Industries (CPI)
📍 Puslinch

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