Dental Product Assessor (MDR) > SGS > Joboolo BE :
Company : SGS Location : Antwerp Flanders From : Talent BE
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.QualificationsOver 4 years of professional expertise in the dentalproducts 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 dentalproducts, or in positions requiring an in-depth understanding of the scientific principles underpinning these products or technologies.Previous experience in conducting dentalproduct 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 reportsDemonstrated 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. SGS AntwerpFlanders
