Senior Biosafety Specialist for Medical Devices

1 day ago


Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full time
About the Role

In this key position, you will play a pivotal role in ensuring the biological safety of our medical devices. As a Senior Biosafety Specialist, your primary responsibility will be to conduct comprehensive biological evaluations of our products under development. This entails assessing potential regulatory risks associated with all components included in our hearing aids.

You will work closely with our material expert colleague to facilitate the selection of materials that pose the smallest risk from a health and safety perspective. This collaborative effort enables us to contribute significantly to the development process by identifying the most suitable materials for our products.

The Team you will be part of is dedicated to ensuring biological safety, maximum durability, and highest quality of our medical devices. Our team of 17 people works together to achieve this goal, and we are seeking a new colleague to join our biosafety team to meet the need for biological evaluation of our increasingly ambitious portfolio of products under development.

You will be joining a highly professional and dynamic team that shares the ambition of supporting our business timely and efficiently by state-of-the-art biological evaluations.

  • Prepare biological evaluations plans
  • Compile available data on materials, processes, use, and degradation over the lifecycle
  • Perform biological risk assessment of materials and processes
  • Coordinate with external chemical and biological testing labs (CROs)
  • Report on biocompatibility studies and carry out toxicological risk assessment
  • Prepare biological evaluation reports


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