Product Assessor for Orthopaedic (Notified Body)

SGS is seeking a dedicated Product Assessor to join our team, focusing on orthopaedic medical devices. In this role, you will play a pivotal part in conducting technical documentation reviews and clinical assessments to ensure compliance with the European Medical Device Regulation (EU MDR 2017/745) and the UK Medical Device Regulation (UK MDR 2002) for Class IIa, IIb, and Class III devices.

Key responsibilities

• Conduct thorough technical and clinical assessments of non-active orthopaedic medical devices.
• Identify and rectify instances where device technical documentation deviates from compliance requirements.
• Support CE and UKCA marking activities while maintaining high standards of regulatory integrity.
• Contribute to the training and qualification of junior staff and develop comprehensive training materials.
• Communicate effectively with clients and stakeholders to minimize regulatory risks associated with certification.

Requirements

• Minimum of 4 years of professional experience in the orthopaedic sector, including at least 2 years in design, manufacturing, or testing.
• Master's degree, PhD, or equivalent in a related discipline such as biomedical engineering or medicine.
• Strong understanding of essential standards for orthopaedic products and regulatory frameworks.
• Excellent written English skills for reviewing and querying complex technical documentation.
• Proven ability to learn independently and manage scheduled work efficiently.

What we offer

• Opportunity to work with a globally recognized leader in the Testing, Inspection, and Certification industry.
• Access to extensive professional development resources through SGS University and Campus.
• A collaborative, multinational work environment with colleagues from across the globe.
• Comprehensive benefits platform designed to support your long-term growth and well-being.