Product Assessor for Orthopaedic (Notified Body)
- Full-time
We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading integral company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.
As a Product Assessor, you will play a pivotal role in conducting orthopaedic product assessments and technical documentation reviews in strict adherence to European Medical Device Regulation (EU MDR 2017/745)
and the UK Medical Device Regulation (UK MDR 2002) and for Class IIa/IIb and/or Class III devices.
Key Responsibilities:
- Conduct thorough technical and clinical assessments of non-active orthopaedic medical devices under relevant commission regulation codes, with potential to extend expertise to dental devices.
- Identify and rectify instances where device technical documentation deviates from compliance with applicable requirements.
- Provide support for CE and UKCA marking activities within SGS.
- Contribute to the training and qualification of junior staff and develop comprehensive training materials.
- Communicate effectively with team members, clients, and other stakeholders regarding product assessments, working diligently to minimise regulatory risks associated with medical device certification.
- Ensuring diligent management of scheduled work to maintain timeliness and efficiency in deliverabl