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Biological Evaluation Specialist to Medical Devices

2 months ago


Ballerup, Ballerup Kommune, Denmark GN Group Full time

About the Role

We are seeking a highly skilled Biological Evaluation Specialist to join our Materials & Reliability Development department at GN Group. As a key member of our team, you will play a crucial role in ensuring the biological safety, durability, and quality of our medical devices.

Key Responsibilities

  • Develop and implement biological evaluation plans for our medical devices
  • Compile and analyze data on materials, processes, and degradation over the lifecycle of our products
  • Perform biological risk assessments of materials and processes
  • Coordinate with external testing labs to ensure compliance with regulatory requirements
  • Prepare and submit biocompatibility studies and toxicological risk assessments
  • Develop and maintain documentation and reports related to biological evaluations

Requirements

  • Bachelor's degree or higher in a relevant field, such as biology, chemistry, or engineering
  • Proven experience in biological evaluation, biosafety, and toxicology
  • Knowledge of regulatory requirements and industry standards, such as ISO
  • Excellent communication and collaboration skills
  • Fluency in English, both written and spoken

About GN Group

GN Group is a leading provider of intelligent hearing, audio, video, and gaming solutions. We are committed to enhancing the senses of hearing and sight, and we strive to make a positive impact on people's lives. Our team is passionate about innovation and collaboration, and we are looking for like-minded individuals to join us on our journey.