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Senior Product Assessor
2 mesi fa
Are you a seasoned professional looking to take your career to the next level in the field of medical device certification? If you have a strong background as a Product Assessor/Specialist/Technical File Reviewer within a Notified Body for active devices, conducting reviews against MDD and/or MDR, then we have an exciting opportunity for you
Key Responsibilities:
- Support and guide a team of 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 in the certification process.
- Monitor the team's 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.
Requirements:
- 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.
