Product Evaluator
4 weeks ago
As a Product Assessor at SGS, you will play a critical role in ensuring the technical integrity of medical devices. Your primary responsibility will be to conduct thorough reviews of technical files, identifying potential issues and ensuring compliance with regulatory requirements.
Key Responsibilities- Conduct technical file reviews of Class 11a/11b and/or Class III medical devices, identifying potential issues and ensuring compliance with regulatory requirements.
- Develop and maintain a deep understanding of regulatory requirements, industry standards, and SGS policies and procedures.
- Collaborate with cross-functional teams to ensure efficient service delivery and effective communication with clients.
- Provide technical assistance and support to colleagues, facilitating training and knowledge sharing.
- Stay up-to-date with industry developments and advancements, maintaining personal competence and development in qualified specialist areas.
- Project manage reviews to maximize efficiencies, enhance client satisfaction, and ensure compliance with standards.
- Support and assist on queries raised from the review process.
- Work towards achieving individual and team KPIs, ensuring personal competency is maintained to review technical files and documentation.
- Maintain MDD/MDR or IVD/IVR Product Assessor status.
- 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, and non-implantable surgical devices.
- 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%).
SGS Canada is an equal opportunity employer and is committed to achieving greater accessibility by providing accommodation for people with disabilities during our hiring process. Accommodations are available on request for qualified candidates during each stage of the recruitment process.
Please note that candidates applying for Canadian job openings should be authorized to work in Canada.
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Product Evaluator
4 weeks ago
Mississauga, Ontario, Canada SGS Full timeJob OverviewSGS is seeking a highly skilled Product Assessor to join our team. As a Product Assessor, you will play a critical role in ensuring the quality and safety of medical devices.Key ResponsibilitiesConduct thorough technical file reviews of Class 11a/11b and/or Class III medical devices to ensure compliance with regulatory requirements.Review and...
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Product Evaluator
4 weeks ago
Mississauga, Ontario, Canada SGS Full timeJob OverviewSGS is seeking a highly skilled Product Assessor to join our team. As a Product Assessor, you will play a critical role in ensuring the quality and safety of medical devices.Key ResponsibilitiesConduct thorough technical file reviews of Class 11a/11b and/or Class III medical devices to ensure compliance with regulatory requirements.Review and...
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