col-wideJob Description:
Job Description
We currently have an exciting opportunity at SGS for a Product Assessor – Orthopaedic and Dental to join our highly successful certification division.
Working as a member of our Medical Device team, reporting directly to Global Medical Devices Technical team manager, you will manage a team of Product Assessors (globally based) within the Orthopaedic and Dental Devices field.
As part of this role, you will be responsible for:
Monitoring the team's technical competence, KPIs, and wellbeing and providing feedback and support when there are concerns.
Supporting with onboarding of new starters and developing training plans and their follow-up.
Conducting technical file reviews against European Medical Device Directive (including UKCA) and Medical Device Regulation for Class IIa/IIb/III.
Develop training as and when required and present the training to others in SGS or externally as deemed necessary.
Conduct recruitment, including reviewing CVs and undertaking interviews.
Maintain personal competence and development in qualified specialist areas to be able to assess product technical documentation on an ongoing basis.
Project manage assessments as appropriate to maximize efficiencies, enhance client satisfaction, and ensure compliance with requirements.
Assist with technical queries and those related to sales within the Ortho and dental Devices field.
Ensure that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery.
Qualifications
Please submit English CV for application.
Previous experience as a Product Assessor/Specialist/Technical File Reviewer within another Notified Body for Orthopaedic and Dental devices conducting reviews against MDD and/or MDR is required.
Four years of professional experience in the field of healthcare products or related activities, such as design, manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed;
Orthopaedic and Dental Devices knowledge through designing, manufacturing or testing of devices such as;
Non-active osteo- and orthopaedic implants (MDN1102)
Prosthetic joint replacements ( 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
Non-active, non-implantable dental material (MDN1209)
Previous Management experience is desired but not compulsory.
Fluency in English speaking and writing is a must have.