Full-Time Product Assessor - Orthopaedics

As a Product Assessor, you'll conduct Orthopaedics technical file reviews, adhering to UK and EU Medical device regulations (Class IIa/IIb/III). Ensure product safety and intended performance, and compliance.

Support CE marking activities (SGS), train junior staff, and create training materials.

Communicate with team members and clients regarding product assessments, minimizing risks in medical device certification.

Required for Application: English CV

Experience Requirements: Minimum 4 years professional experience in healthcare products, or related fields (design, manufacturing, auditing, research), including two years in design, manufacture, or testing related to MDN1102 and joint replacements.

Preferred Qualifications: Experience conducting Orthopaedic assessments for another Certification/Notified body (Technical File reviewer). Degree or equivalent related to medicine, engineering, or relevant sciences.

Essential Skills: Good communication (electronic mediums), strong written English (reports), medical device knowledge in:

• Non-active osteo- and orthopaedic implants (MDN1102)
• Prosthetic joint replacements (knee, hip, etc.)
• Artificial spinal disc, spinal cages
• Bone graft substitute, bone cements
• Osteosynthesis devices (nails, screws, plates, etc)

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