Job Description
The Technical Training Specialist will be a key member of our team, responsible for the design, development, and delivery of specialized training programs for our Notified Body, which delivers CE certification services for in-vitro diagnostic medical devices.
As part of the Global Medical Device Training Team, you will be supporting the training needs of our dynamic and rapidly growing team of experts, on broad ranging topics including the clinical and technical aspects of IVD assays, the regulatory requirements of the EU In-vitro Diagnostic Medical Device Regulation, as well as relevant guidance documents and standards (ISO 13485, ISO 14971, various CLSI guidance etc.).
This role is integral to ensuring that our team possess the necessary skills and knowledge for effective conformity assessments in the ever-evolving landscape of medical device regulations.
The Global Medical Devices Technical Training Specialist contributes to the ongoing competence and professional development of the team, thereby enhancing the overall capabilities of the Notified Body.
Apply now to be a vital part of our motivated and dynamic team!
Specific Responsibilities:Training Course Preparation: Support the Training team in preparing and maintaining core training courses related to IVD medical devices leveraging your own technical knowledge as well as collaborating with subject matter experts to ensure training content is effective in achieving the defined learning outcomes.Training Delivery: Deliver and coordinate the delivery of webinars, workshops, peer-review activities and other training content.Regulatory Knowledge: Maintain up-to-date knowledge of relevant medical device regulations.External Training Support: Support and/or deliver external trainings, including administrative support.Peer Reviews and Assessments: Assist the Training team in conducting peer reviews and assessment marking for mock audits/technical file reviews.QualificationsEssential:Experience in the field of in vitro diagnostic medical devices gained in the IVD industry, clinical diagnostics laboratory, relevant research, IVD regulatory affairs, or other relevant professional setting.Bachelor level education, preferably in engineering, science, or a healthcare-related domain. IT literacy.Proven experience in progressively training technical skills, preferably within multinational organizations both in online and face to face methodologies.Teaching & Mentoring Skills: Ability to effectively impart knowledge and support the learning process.Excellent communication skills to convey complex information clearly.Prioritizing the needs and expectations of internal stakeholders.Ability to manage projects and collaborate within a team environment.IT literacy.Establishing and maintaining positive relationships with stakeholders.Strong English literacy.Desirable:Good understanding of the EU IVDR and key international standards applicable to medical devices.
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