FAQs
What is the primary responsibility of the Technical Training Specialist?
The primary responsibility of the Technical Training Specialist is to design, develop, and deliver specialized training programs for the Notified Body that provides CE certification services for in-vitro diagnostic medical devices.
What topics will the training programs cover?
The training programs will cover a broad range of topics including clinical and technical aspects of IVD assays, EU In-vitro Diagnostic Medical Device Regulation, relevant guidance documents, and standards such as ISO 13485 and ISO 14971.
What qualifications are essential for this role?
Essential qualifications include experience in the field of in vitro diagnostic medical devices, a bachelor level education preferably in engineering, science, or healthcare, proven experience in training technical skills, and excellent communication skills.
Is experience in the IVD industry required for this role?
Yes, experience in the IVD industry, clinical diagnostics laboratory, relevant research, IVD regulatory affairs, or other relevant professional settings is essential.
Will the Technical Training Specialist conduct training sessions?
Yes, the Technical Training Specialist will deliver and coordinate webinars, workshops, peer-review activities, and other training content.
What is the team structure the Specialist will work within?
The Specialist will be a key member of the Global Medical Device Training Team, collaborating with a dynamic and rapidly growing team of experts.
Is IT literacy required for this position?
Yes, IT literacy is required, as it is essential for training delivery and project management.
What are some desirable qualifications for candidates?
A good understanding of the EU IVDR and key international standards applicable to medical devices is considered a desirable qualification.
Will the Technical Training Specialist support external training events?
Yes, the Specialist will support and/or deliver external training sessions, including providing administrative support.
What types of training methodologies are expected to be utilized?
Both online and face-to-face training methodologies are expected to be used in this role.