Biological Evaluation Specialist for Medical Devices

4 weeks ago


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

In this role, you will be responsible for conducting biological evaluations of our medical devices to ensure their safety and efficacy.

You will work closely with our materials expert to assess potential regulatory risks associated with our products and contribute to the development process by selecting materials that pose the smallest risk from a health and safety perspective.

The Team You Will Be Part Of:

You will join a team of 17 professionals in our Materials and Reliability Development department, dedicated to ensuring biological safety, maximum durability, and highest quality of our medical devices.

Your Key Responsibilities:

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

Requirements:

  1. Bachelor's degree or higher in a relevant field, such as science, biology, chemistry, or engineering
  2. Experience with polymer chemistry and manufacturing processes, preferably in R&D or manufacturing
  3. Knowledge of toxicology or risk management, preferably in a medical device or pharmaceutical context
  4. Excellent communication and collaboration skills
  5. Fluency in English

We Encourage You to Apply:

Even if you don't match all the requirements, we welcome your application if you think you have transferable skills and the right mindset.

We value diversity and inclusion in our recruitment process and offer equal consideration to all applicants.

About GN Store Nord A/S:

GN Store Nord A/S is a leading company in the field of intelligent hearing, audio, video, and gaming solutions. We deliver technology that enhances the senses of hearing and sight, helping people with hearing loss overcome real-life challenges and improving communication and collaboration for businesses.



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

    Biological Evaluation Specialist for Medical DevicesIn this role, you will be responsible for performing biological evaluations of our medical devices to ensure their safety and efficacy. You will work closely with our materials expert to assess potential regulatory risks and contribute to the development process by selecting the right materials.The Team You...


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

    In the role as Biological Evaluation Specialist, your primary responsibility will be to conduct thorough biological evaluations of our medical devices under development. You will contribute to the assessment of potential regulatory risks of all components included in our hearing aids. This enables us to select the right materials that pose the smallest risk...


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

    In the role as Biological Evaluation Specialist, your primary responsibility will be to conduct thorough biological evaluations of our medical devices under development. You will contribute to the assessment of potential regulatory risks of all components included in our hearing aids. Together with our material expert colleague, this enables us to support...


  • Ballerup, Ballerup Kommune, Denmark Ambu Full time

    Are you a skilled engineer looking to make a meaningful impact in the medical device industry? Do you have a passion for systems engineering and a desire to work on innovative products that improve patient outcomes? We may have the perfect opportunity for you!Ambu is a global leader in medical devices, and we're seeking a talented Systems Engineer to join...


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

    About the JobIn this role as Design Controller, you will be a crucial part of GN\'s mission to Bring People Closer. Your primary responsibility will be to ensure compliance with the corporate Quality Management System and regulated standards in Medical Device SW projects. You will plan and implement Design Control deliverables, facilitating design reviews,...


  • Ballerup, Ballerup Kommune, Denmark Ambu Full time

    About the RoleWe are seeking a highly skilled Senior Medical Device Systems Engineer to join our team at Ambu. As a key member of our R&D team, you will play a critical role in the development of innovative medical devices that significantly impact patients' lives.Key ResponsibilitiesEstablish and maintain project documentation, ensuring compliance with FDA...


  • Ballerup, Ballerup Kommune, Denmark Ambu Full time

    Job Title: Experienced R&D EngineerAmbu is seeking an Experienced R&D Engineer to join our Mechanical Design team. In this role, you will be responsible for the development of novel medical devices, working closely with external partners and internal teams.Key Responsibilities:Identify user needs, design inputs, and specifications through participation in...


  • Ballerup, Ballerup Kommune, Denmark Ambu Full time

    About the RoleWe are seeking an experienced Systems Engineer to join our team at Ambu, a global MedTech company disrupting the endoscopy market. As a key member of our R&D team, you will play a crucial role in developing innovative products that significantly impact patients' lives.Key ResponsibilitiesEstablish and maintain project documentation, ensuring...


  • Ballerup, Ballerup Kommune, Denmark GN Group Full time

    About the RoleWe are seeking a highly skilled Qualitative Evaluation Specialist to join our team at GN Group. As a key member of our System Verification department, you will be responsible for designing and leading studies to evaluate our Audio-Video products and solutions.Key ResponsibilitiesDevelop and implement research plans to address user behavior and...


  • Ballerup, Ballerup Kommune, Denmark GN Group Full time

    About the RoleWe are seeking a highly skilled Qualitative Evaluation Specialist to join our team at GN Group. As a key member of our System Verification department, you will play a crucial role in evaluating our Audio-Video products and solutions using qualitative research methods.Key ResponsibilitiesDesign and lead studies to understand user behavior and...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    About the RoleAs a Senior Scientist/Specialist for Biotherapeutic Discovery and Engineering at Novo Nordisk, you will play a key role in driving the execution of cutting-edge technologies for antibody and protein domain repertoire generation and characterization. Your responsibilities will include:Proactively driving the execution of display-based...


  • Ballerup, Ballerup Kommune, Denmark Ambu Full time

    Are you looking for a challenge as a quality professional in the medical device industry? Do you have a passion for quality management and compliance?We are seeking an experienced Head of Global Quality Management Operations to join our pioneering Quality Management team. This is an excellent opportunity to work in a dynamic and international environment,...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    Are you a highly skilled and motivated scientist with a passion for AI-driven biologics discovery? We are seeking a talented individual to join our team at Novo Nordisk A/S as a Principal Scientist for exploratory research.The PositionLead and conduct research in AI data generation for biologics discovery.Evaluate new technologies and recommend the...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    Are you a highly skilled and motivated scientist with a passion for AI-driven biologics discovery? We're seeking a talented individual to join our team at Novo Nordisk A/S, where you'll have the opportunity to work at the cutting edge of biologics research, leveraging advanced AI techniques to revolutionize the field.The PositionLead and conduct research in...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    Are you a talented molecular biologist passionate about leveraging AI techniques to revolutionize biologics discovery?As a Senior Molecular Biologist at Novo Nordisk, you will lead research in AI data generation, evaluate new technologies, and stay current with the latest advancements in molecular biology. You will also contribute to the design and...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled and passionate Senior Scientist/Specialist to join our Department of Recombinant Drug Discovery at Novo Nordisk. As a key member of our team, you will play a crucial role in driving forefront technologies for early discovery and engineering of recombinant biologics and tool antibodies.Key...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Cell Therapy Formulation Specialist to join our team at Novo Nordisk. As a key member of our Cell Therapy Platform Technologies department, you will play a critical role in developing formulations and methods for the cryogenic storage and transportation of cell therapy drug products.As a specialist in cell...


  • Ballerup, Ballerup Kommune, Denmark Ambu Full time

    Are you passionate about developing innovative medical devices and taking charge of complex projects? Ambu is currently seeking an experienced R&D Engineer to join our Mechanical Design team. In this role, you will be responsible for designing and developing novel medical devices, collaborating with cross-functional teams, and ensuring the highest level of...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    Job SummaryWe are seeking a highly skilled Cell Therapy Formulation Specialist to join our team at Novo Nordisk. As a key member of our Cell Therapy Formulation & Cryopreservation Department, you will play a critical role in developing formulations and methods for the cryogenic storage and transportation of cell therapy drug products.Key...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Senior Scientist/Specialist to join our Department of Recombinant Drug Discovery at Novo Nordisk. As a key member of our team, you will play a crucial role in driving forefront technologies for early discovery and engineering of recombinant biologics.Key ResponsibilitiesProactively drive execution of...