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Senior Product Assessor
1 mese fa
We are seeking a highly skilled Senior Product Assessor to lead our team of Product Assessors in the field of Active Medical Devices. As a Senior Product Assessor, you will be responsible for conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards.
Your key responsibilities will include:
- Supporting and guiding your team of Product Assessors
- Conducting technical documentation reviews and ensuring compliance with EU regulations and standards
- Collaborating with cross-functional teams to increase efficiency and quality
- Monitoring the team's technical competence, KPIs, and wellbeing and providing feedback and support when necessary
- Recruitment, including reviewing CVs and undertaking interviews and supporting with onboarding of new starters
- Developing training and presenting the training to others in SGS or externally as deemed necessary
- Assisting with technical queries and those related to sales within the Active Medical Devices field
To be eligible for this role, you should have prior experience as a Product Assessor/Specialist/Technical File Reviewer within another Notified Body for active devices, conducting reviews against MDD and/or MDR.
Additionally, you must possess:
- Four years of professional experience in the field of healthcare products or related activities, such as design, manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed;
- 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.
As a Senior Product Assessor at SGS, you will have the opportunity to make a significant impact in the field of certification and contribute to the growth and success of our dynamic team.