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Technical Lead

2 months ago

Ballerup, Ballerup Kommune, Denmark GN Group Full time
Technical Lead - Device Investigation Expert

GN Group is seeking a highly skilled Technical Lead to join our Regulatory Product Surveillance team. As a key member of our team, you will be responsible for leading the device investigation process, providing critical insights for new product development, design, and risk management.

Key Responsibilities:
  • Manage the device investigation process, including hands-on examination of devices
  • Provide vital insights for new product development, design, and risk management
  • Maintain and improve current device investigation protocols
  • Facilitate and support other post-market surveillance activities
  • Plan, report, and document in collaboration with stakeholders
Requirements:
  • Engineering or technical degree
  • Curiosity in and knowledge of medical devices, regulatory environment, quality systems, risk management, and vigilance
  • Knowledge of standards like ISO 13485, ISO 14971, MDR
  • Experience working with Power BI or other smart solutions
  • Experience with scientific writing and audit/inspections
  • Experience working with customer feedback or vigilance related to medical devices
About GN Group:

GN Group brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. We deliver technology that enhances the senses of hearing and sight, enabling people with hearing loss to overcome real-life challenges and improve communication and collaboration for businesses.