Senior Product Assessor
2 weeks ago
We are seeking a highly skilled Senior Product Assessor to join our dynamic team at SGS. As a key member of our Active Medical Devices team, you will be responsible for conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards.
Key Responsibilities- Support and guide a team of Product Assessors in conducting technical documentation reviews and ensuring compliance with EU regulations and standards.
- Collaborate with cross-functional teams to increase efficiency and quality.
- Monitor team technical competence, KPIs, and wellbeing, and provide feedback and support when necessary.
- Conduct recruitment, including reviewing CVs and undertaking interviews, and support with onboarding new starters.
- Develop and present training to others in SGS or externally as deemed necessary.
- Assist with technical queries and those related to sales within the Active Medical Devices field.
- Ensure the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery.
- Prior experience as a Product Assessor/Specialist/Technical File Reviewer within another Notified Body for active devices, conducting reviews against MDD and/or MDR.
- Four years of professional experience in the field of healthcare products or related activities, such as design, manufacturing, auditing, or research.
- Active Medical Devices knowledge through designing, manufacturing, or testing of such devices.
- Thorough knowledge and understanding of related standards: EN 60601, EN 62304, EN 62366, etc.
- Good written English skills, as reports will be reviewed/queried in English.
- Knowledge of the following Technical File codes desirable (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017): MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and MDA0318.
We are looking for a highly skilled and experienced Senior Product Assessor to join our team at SGS. If you have a strong background in product assessment and a passion for delivering high-quality results, we encourage you to apply for this exciting opportunity.
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