As a Product Assessor you ll conduct technical file reviews to ensure that products are safe and perform as intended in compliance with all applicable requirements including UK and EU medical device regulation.
You ll also support CE marking activities and communicate with colleagues and clients regarding product assessment and other activities, working to minimise risks associated with medical device certification.
- Degree or equivalent experience in medicine, dentistry, biotechnology, engineering or other relevant fields
- 4+ years of professional experience in the orthopaedic/dental products sector or related fields, covering roles in design, manufacturing, auditing, or research. Crucially, a minimum of two years should be directly involved in the design, manufacturing, and testing of dental products, or in roles that require a deep understanding of the scientific principles underlying these products or technologies.
- Prior experience conducting orthopaedic or dental product assessments for a Certification/Notified Body (acting as a Technical Documentation Reviewer) is advantageous
- Strong communication and stakeholder management skills
- Professional English
- Orthopaedic and Dental Device knowledge through designing, manufacturing, or testing of devices in some or all the following areas
Non-active osteo- and orthopaedic implants (MDN1102)
- Prosthetic joint replacements (i.e. knee, hip, shoulder, elbow, wrist, ankle, fingers, etc implants)
- Artificial spinal disc, spinal cages
- Bone graft substitute for orthopaedic indications, bone cements, etc
- Osteosynthesis devices such as orthopaedic nails, screws, plates, etc
Non-active dental implants and dental material (MDN1103)
- Dental implants abutments, Root canal filler, etc
Non-active, non-implantable dental material (MDN1209)
- Etching solutions, Braces, Dental cements
