Senior Product Assessor

il y a 3 semaines


Les PavillonssousBois, Île-de-France SGS Temps plein
Job Title: Senior Product Assessor - Active Devices

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 compliance of medical devices 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 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:
  • 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, 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.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.


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