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 deliverables.