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Biological Evaluation Specialist to Medical Devices

GN Store Nord A/S



In the role as Biological Evaluation Specialist your primary role will be to perform biological evaluations of our products under development.

You will contribute to the assessment of potential regulatory risks of all the components included in our hearing aids. Together with our material expert colleague this enables us to help in the development process by selecting the right materials that pose the smallest risk from a health- and safety perspective.

The Team you will be part of
At our offices in Ballerup, a team of 17 people work within our team of Materials & Reliability Development are dedicated to ensuring biological safety, maximum durability and highest quality of our medical devices. We are for our biosafety team looking for a new colleague 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. We share the ambition of supporting our business timely and in a efficient way by state of the art biological evaluations.

Your contribution will be to:

  • Preparing biological evaluations plans
  • Compile available data on materials, processes, use and degradation over 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.

To succeed in the role, we imagine that you
You thrive in a position where you compile relevant information by reaching out to internal and external stakeholders across different expertise areas. Ideally, you have already worked with biological evaluation prior, or you are interested in developing your skills within biosafety, toxicology, chemical risk assessment, and medical devices.

Furthermore, you:

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

We encourage you to apply
Even if you don’t match all the above-mentioned skills, we gladly receive your application if you think you have transferrable skills. We highly value the right mindset; motivation and energy and we believe that the right personal competencies are highly important for creating success.

We are dedicated to an inclusive recruitment process and all applicants will receive equal consideration for employment.

Join us in bringing people closer
GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.

How to apply?
To apply, use the ‘APPLY’ link no later than August 15, 2024.

Please observe the long application period to allow for applications throughout the summer vacation period.

Applications are assessed on a continuous basis, so don’t wait to send yours.

When submitting your up-to-date CV, please include a few sentences at the top of your CV outlining:

What you can contribute with in Biosafety, within the field of medical devices?

We encourage you to submit your CV without a photo to ensure an equal and fair application process.

If you would like to know more about the position, please contact Manager Materials and Reliability Henrik Povelsen on: mobile: +45 23 66 02 87 or email: [email protected]

We hope you will join us on this journey and look forward to receiving your application.

#LI-GNGroup

Location: Ballerup

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GN Store Nord A/S

Lautrupbjerg 7, 2750 Ballerup

GN addresses medical, professional and consumer segments with solutions that improve quality of life, facilitate communication and enhance business and personal productivity. Our brands are all based on the group’s core engineering expertise and technologies. We develop and manufacture innovative and intelligent audio and video communications solutions that are marketed and sold in around 100 countries across the world.

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