Regulatory Safety Expert for Medical Devices and Hearing Aids

1 month ago


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

In this pivotal role as Regulatory Safety Expert, you will play a crucial part in ensuring the safety and efficacy of our medical devices, specifically hearing aids. Your primary responsibility will be to conduct thorough biological evaluations of our products under development, working closely with our Materials & Reliability Development team.

You will contribute significantly to assessing potential regulatory risks associated with the components of our hearing aids, collaborating with our material expert colleague to select materials that pose the smallest risk from a health- and safety perspective. This enables us to facilitate an efficient development process, guaranteeing the highest quality and durability of our medical devices.

The Team You Will Be Part Of

Our offices in Ballerup are home to a dynamic team of 17 professionals within the Materials & Reliability Development department, dedicated to ensuring biological safety, maximum durability, and exceptional quality of our medical devices. We are seeking a new colleague to join our biosafety team to meet the increasing demand for biological evaluation of our ambitious portfolio of products.

You will be joining a highly professional and dynamic team, united by our ambition to support our business with state-of-the-art biological evaluations in a timely and efficient manner.

Your Key Responsibilities
  • Prepare comprehensive biological evaluation plans
  • Gather available data on materials, processes, use, and degradation over the lifecycle
  • Perform thorough biological risk assessments of materials and processes
  • C Coordinate with external chemical and biological testing labs (CROs)
  • Report on biocompatibility studies and carry out toxicological risk assessment
  • Prepare detailed biological evaluation reports
Requirements

To succeed in this role, we envision that you:

  • Thrives in positions where you compile relevant information by engaging with internal and external stakeholders across diverse expertise areas
  • Hold a bachelor's degree or higher in science, biology, chemistry, 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 possess other relevant experience within medical devices, pharma/life-science
  • 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 candidates who do not match all the above-mentioned skills to apply if they believe they can bring transferable skills to the table. We value motivation, energy, and the right personal competencies, which are essential for creating success.

We strive for an inclusive recruitment process, and all applicants will receive equal consideration for employment.

Salary: Approximately $80,000 - $110,000 per year

This salary range is based on industry standards for similar roles in the location, considering factors such as cost of living, job requirements, and market conditions.



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