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Product Specialist
2 months ago
Job Summary
As a Product Assessor at SGS, you will conduct thorough technical file reviews of Class 11a/11b and/or Class III medical devices to ensure compliance with regulations, standards, and guidelines.You will be responsible for approving or raising queries based on your technical and procedural knowledge.Ensure that reviews are technically sound and in compliance with applicable regulations, standards, guidelines, and competent authority expectations.Provide efficient service delivery and meet customer requirements while adhering to SGS Policies, procedures, and processes.Maintain personal competence and development in qualified specialist areas on an ongoing basis.Requirements
Bachelor's degree in a related discipline (medicine, pharmacy, engineering, or other relevant sciences).Minimum 4 years of experience in the field of healthcare products or related industry (manufacturing, auditing, or research).Active knowledge of medical devices, including stand-alone software devices, non-implantable devices for monitoring vital physiological parameters, and non-implantable devices utilizing hyperthermia/hypothermia.Minimum 2 years in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed.A broad range of codes and previous Technical File review experience.Ability to travel across Canada and the US (Up to 50%).