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Senior Product Assessor
1 mese fa
We are seeking a highly skilled and experienced Senior Product Assessor to join our dynamic team at SGS. As a Senior Product Assessor, you will play a key role in ensuring the highest level of service is provided throughout the SGS network, offering medical devices certification and stakeholders through efficient service delivery.
Key Responsibilities:- Support and guide a team of talented Product Assessors in conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards.
- Collaborate with cross-functional teams to increase efficiency and quality.
- Monitor the team's technical competence, KPIs, and wellbeing, and provide feedback and support when there are concerns.
- Conduct recruitment, including reviewing CVs and undertaking interviews, and support with onboarding of new starters.
- Develop training and present the 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.
- 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.
Please note that knowledge of the following Technical File codes is desirable: MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and MDA0318.