Biological Evaluation Expert for Medical Devices Innovation

2 days ago


Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full time

As a Biological Evaluation Specialist at GN Store Nord A/S, you will play a pivotal role in ensuring the biological safety and quality of our medical devices. In this dynamic position, your primary responsibility will be to conduct thorough biological evaluations of our products under development.

You will work closely with our material expert colleague to select materials that pose the smallest health and safety risk, thereby minimizing potential regulatory risks associated with all components included in our hearing aids.

The Team You Will Be Part Of:

Our Materials & Reliability Development department is comprised of 17 highly skilled professionals dedicated to ensuring the highest quality of our medical devices. As a member of our biosafety team, you will contribute to conducting state-of-the-art biological evaluations in a timely and efficient manner.

Your Key Responsibilities:

  1. Develop comprehensive biological evaluation plans
  2. Compile available data on materials, processes, use, and degradation over the lifecycle
  3. Perform rigorous biological risk assessments of materials and processes
  4. Coordinate with external chemical and biological testing labs (CROs)
  5. Report on biocompatibility studies and carry out toxicological risk assessments
  6. Prepare detailed biological evaluation reports

To Succeed In This Role:

We seek an individual with excellent communication skills who can effectively compile relevant information by reaching out to internal and external stakeholders across different expertise areas. Ideally, you have prior experience working with biological evaluation or are eager to develop your skills within biosafety, toxicology, chemical risk assessment, and medical devices.

Furthermore, you should:

  1. Hold a bachelor's degree or higher in science, biology, chemical engineering, or a similarly relevant field
  2. Be well-versed in polymer chemistry and manufacturing processes, possibly from previous positions in R&D or manufacturing
  3. May have worked with biological evaluation prior or have other relevant experience within e.g., medical devices or pharma/life-science
  4. May have knowledge and experience within toxicology or risk management
  5. Proactively engage with internal stakeholders (e.g., multidisciplinary project groups) and external stakeholders (e.g., external experts, partners, regulatory authorities)
  6. Be fluent in English

What We Offer:

As a Biological Evaluation Specialist at GN Store Nord A/S, you will join a company that prioritizes innovation and excellence in the field of medical devices. We offer a dynamic work environment, opportunities for growth and development, and a competitive salary commensurate with experience.

We value the right mindset, motivation, and energy, and believe that personal competencies are essential for creating success. If you think you have transferable skills or are eager to develop your skills within biosafety, toxicology, or related fields, we encourage you to apply.



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