FAQs
What is the primary responsibility of the Technical Training Specialist in Global Medical Devices?
The primary responsibility 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 are some topics that the Technical Training Specialist will cover in training programs?
The topics include the clinical and technical aspects of IVD assays, regulatory requirements of the 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’s degree in engineering, science, or a healthcare-related domain, proven experience in training technical skills, and excellent communication and project management skills.
Is experience in the IVD industry necessary?
Yes, experience in the IVD industry, clinical diagnostics laboratory, or relevant regulatory affairs is essential for this role.
Will the Specialist need to deliver training in different formats?
Yes, the Specialist will need to deliver training in various formats, including webinars, workshops, and face-to-face methodologies.
What languages should the candidate be proficient in?
Strong English literacy is required for this role, as effective communication is essential for conveying complex information clearly.
Is there a focus on stakeholder management in this role?
Yes, establishing and maintaining positive relationships with stakeholders and prioritizing their needs and expectations is important.
Are there any desirable qualifications for this position?
A good understanding of the EU IVDR and key international standards applicable to medical devices is considered a desirable qualification.
Does the position involve collaboration with other team members?
Yes, the position requires collaboration within a team environment to manage projects and support training delivery.
What kind of training methods will be utilized in this role?
The role will utilize both online and face-to-face methodologies to effectively impart knowledge and facilitate learning.