Product Assessor

7 months ago


Mississauga, Canada SGS Full time
Job Description Product Assessor will conduct technical file reviews of Class 11a/11b and/or Class III and approve or raise queries based on technical and procedural knowledge. Ensure reviews are technically sound and in compliance with all applicable regulations, standards, guidelines, and competent authority expectations. Ensure that the highest level of service is provided through efficient service delivery and those customer requirements are met while adhering to SGS Policies, procedures, and processes. As a member of the Global Medical Device office (MDO) to minimize risks associated with medical device certification. Act as a support/leader to the defined group in terms of technical assistance, facilitate training, communication, assistance with widening the codebase. Maintain personal competence and development in qualified specialist areas on an ongoing basis Project manage reviews as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards To support/assist on queries raised from the review Work at all times to adhere to KPI’s set as an individual and within a team To ensure personal competency is maintained to be able to review technical files and technical documentation Maintenance of MDD/MDR or IVD/IVR Product Assessor status

Qualifications

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 Medical Devices knowledge :stand-alone software devices, etc. through designing, manufacturing, or testing of such devices;non-implantable device for monitoring,non-implantable device for monitoring vital physiological parameters,non-implantable devices utilizing hyperthermia / hypothermia,non-implantable surgical devicenon-implantable devices for wound and skin care 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%)


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