Dental Product Assessor

1 mese fa

Milan, Italia SGS A tempo pieno
Job Description

As a Product Assessor , you will play a crucial role in performing assessments on dental products and reviewing technical documentation in strict accordance with the European Medical Device Regulation (EU MDR 2017/745) and the UK Medical Device Regulation (UK MDR 2002) for Class IIa/IIb and/or Class III devices.

Primary Duties:

Conduct in-depth technical and clinical evaluations of non-active dental medical devices using relevant commission regulation codes, with the potential to expand expertise to orthopaedic devices. Identify and address instances where device technical documentation deviates from compliance with applicable requirements. Provide assistance for CE and UKCA marking activities at SGS. Contribute to the training and certification of junior staff, creating comprehensive training materials. Effectively communicate with team members, clients, and stakeholders regarding product assessments, working diligently to minimize regulatory risks associated with medical device certification. Ensure meticulous management of scheduled work to maintain timeliness and efficiency in deliverables.

Qualifications

Over 4 years of professional expertise in the dental products sector or related fields, encompassing roles in design, manufacturing, auditing, or research. Significantly, a minimum of two years should be directly engaged in designing, manufacturing, and testing dental products, or in positions requiring an in-depth understanding of the scientific principles underpinning these products or technologies. Previous experience in conducting dental product assessments for a Certification/Notified Body, serving as a Technical Documentation Reviewer, is advantageous. A Master’s degree, PhD, or equivalent in a related discipline, such as medicine, engineering, or biomedical science. Proficiency in modern electronic communication platforms. Strong written English skills are crucial for reviewing and questioning Technical Documentation assessment reports Demonstrated ability to learn independently.

Desirable Skills:

Regulatory Acumen, encompassing knowledge of the European Medical Device Regulation (EU MDR 2017/745) and the UK Medical Device Regulation (UK MDR 2002). Familiarity with medical device codes MDA/MDN/MDS for MDR, as outlined in Commission Implementing Regulation (EU) 2017/2185, is also desirable.

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