SGS is hiring a Remote Évaluateur de produits - Dispositifs médicau
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 (i.e., 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 device
- non-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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