Product Assessor for Orthopaedic (Notified Body)
Core
Conduct technical and clinical assessments of non-active orthopaedic medical devices and review technical documentation for compliance with EU MDR and UK MDR regulations.
Role type
Senior regulatory product assessor (Notified Body)
Builds
CE and UKCA marking support for orthopaedic medical devices
Domain
Medical device regulation / Orthopaedics
Required skills
Orthopaedic product design/manufacturing/testing knowledge, Essential standards for orthopaedic products, Technical documentation review, Regulatory compliance assessment (EU MDR/UK MDR), Training material development
Preferred skills
Dental device assessment experience, Commission regulation codes (MDA/MDN/MDS) familiarity
Technologies
Modern electronic communication platforms
Responsibilities
Conduct technical and clinical assessments of orthopaedic devices, Identify and rectify documentation deviations from compliance, Support CE and UKCA marking activities, Train and qualify junior staff, Manage scheduled work for timeliness
Seniority
Senior, hands-on IC
