Team Manager Orthopaedic and Dental Devices
Client:
SGS
Location:
Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
1ce00c55bb0a
Job Views:
13
Posted:
23.01.2025
Expiry Date:
09.03.2025
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 the 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.
* Developing training as required and presenting the training to others in SGS or externally as deemed necessary.
* Conducting recruitment, including reviewing CVs and undertaking interviews.
* Maintaining personal competence and development in qualified specialist areas to be able to assess product technical documentation on an ongoing basis.
* Project managing assessments as appropriate to maximize efficiencies, enhance client satisfaction, and ensure compliance with requirements.
* Assisting with technical queries and those related to sales within the Orthopaedic and Dental Devices field.
* Ensuring that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery.
Qualifications:
* Three years 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.)
* Bone graft substitutes 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.
* Previous management experience is desired but not compulsory.
* Fluency in English speaking and writing is a must-have.
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