Product Assessor for Orthopaedic (Notified Body)

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. We are seeking an experienced candidate with: - 4+ years of professional experience in the orthopaedic 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 orthopaedic products, or in roles that require a deep understanding of the scientific principles underlying these products or technologies. - Understanding of essential standards for orthopaedic products. - Prior experience in conducting orthopaedic product assessments for a Certification/Notified Body (acting as a Technical Documentation Reviewer) is advantageous. - A Master's degree, PhD, or equivalent in a related discipline, such as medicine, biomedical engineering, or biomedical science, preferably with a focus on orthopaedic devices. - Proficiency in modern electronic communication platforms. - Strong written English skills essential for reviewing and querying Technical Documentation assessment reports. - Demonstrated ability to learn independently. - Desirable: Regulatory Acumen - knowledge of the European Medical Device Regulation (EU MDR 2017/745) and the UK Medical Device Regulation (UK MDR 2002) and familiarity with medical device codes MDA/MDN/MDS for MDR as outlined in Commission Implementing Regulation (EU) 2017/2185.