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Dental Product Assessor

Il y a 2 mois


Antwerpen, Belgique SGS Temps plein

**Company Description**
We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our **99,600 employees operate a network of 2,60**0 offices and laboratories**, working together to enable a better, safer and more interconnected world.

Our **Innovation Factory **promotes and develops digital innovation initiatives across SGS; we deliver solutions to the business at scale and speed. Our mission is to create a better, safer and connected world by supporting, improving or augmenting our physical operations with digital technologies.

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.

**Additional Information** Why SGS?**
- Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
- Enjoy a flexible schedule and remote work model.
- Access SGS University and Campus for continuous learning options.
- Thrive in a multinational environment, collaborating with colleagues from multiple continents.
- Benefit from our comprehensive benefits platform.


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