Medical Device Training Expert

hace 3 semanas


Madrid, Madrid, España SGS A tiempo completo

As a key member of our team at SGS, the Technical Training Specialist will be responsible for designing, developing, and delivering specialized training programs for our Notified Body, which provides CE certification services for in-vitro diagnostic medical devices.

This role is integral to ensuring that our team possesses the necessary skills and knowledge for effective conformity assessments in the ever-evolving landscape of medical device regulations.

The successful candidate will support the training needs of our dynamic and rapidly growing team of experts, covering broad-ranging topics, including the clinical and technical aspects of IVD assays, regulatory requirements, and relevant guidance documents and standards.

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.

Key Responsibilities:

  • Training Course Preparation: Collaborate 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.

Qualifications:

  • 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's 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 and 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 Qualifications:

  • Good understanding of the EU IVDR and key international standards applicable to medical devices.


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