Design Control Compliance Specialist

Would you like to collaborate with colleagues and external stakeholders from across the world to ensure smooth and efficient market access?

In the role as Design Control Compliance Specialist to Medical Devices in GN, you will contribute to our purpose of Bringing People Closer.

The team you will be part of:
At our Headquarters in Ballerup, Denmark, you will join the Design Control team within Corporate Quality, where you will work alongside three colleagues, each an expert in their respective fields. As a member of the Global R&D team, we collaborate to ensure that both new and existing products achieve market access worldwide.

Your contributions are valued, as they will guide and instruct in effective design control compliance.
You will be supporting projects in the R&D organization on everything regarding design control. This includes contributing to product development project progression and ensuring knowledge sharing within the teams. Additionally, it encompasses planning, reporting, and documenting work in close collaboration with various stakeholders.

Furthermore, a crucial aspect of your position will be to plan and execute the design control documentation, which covers usability engineering and risk management, ensuring compliance with the prevailing regulatory standards for medical device development. Specifically, you will:

• Participate in integrating risk management and usability engineering activities
• Share and apply your knowledge within usability engineering documentation
• Identify and analyze risks and define mitigations in collaboration with development teams
• Ensure continuous improvement and optimization of GN Hearing Design Control procedures and templates in collaboration with the other departments
• Participate in design and technical file reviews
• Carry out in-house training of the organization in design control processes

To succeed in the role, we imagine that you:

• You have a few years of experience under your belt, or perhaps a brilliant person fresh out of school. The important thing is that you are a doer with a true passion for medical device and design control.
• Have a good understanding of and experience with ISO 13485, ISO 14971, MDR, IEC 62366-1 and possibly with FDA requirements for the development of medical devices
• Have experience with creating requirements, test plans, test protocols and test reports
• Have experience with usability and risk management
• Have fluent communication skills in both written and spoken English

You have a keen eye for excellent opportunities and maintain a structured approach to your tasks. You possess the ability to listen actively, understanding your colleagues' perspectives, and effectively communicate your insights on guidelines and recommendations, with an emphasis on collaborative efforts. The goal is to establish a solid foundation for R&D within your team.

We encourage you to apply
Even if you don’t match all the above-mentioned skills, we will gladly receive your application if you think you have transferrable skills. We highly value a mindset, motivation, and energy, that aligns with our core values, to not only ensure success for you, but for your team and the wider GN organization as well.

We are dedicated to an inclusive recruitment process
All applicants will receive equal consideration for employment. As such, we encourage you to submit your CV without a photo to ensure an equal and fair application process.

Should you have any special requirements for the interview please let the Hiring Manager know upon accepting he interview invitation.

How to apply?
Use the ‘APPLY’ link no later than August 15th, 2024. Applications are assessed on a continuous basis, so don’t wait to send yours.

On a time crunch? Feel free to only submit your up-to-date CV including a few sentences outlining your motivation for applying – quick and easy.

If you would like to know more about the position, please contact Regulatory Product Compliance Manager, Sarah Søgaard-Hansen on [email protected]

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 enthusiast.

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

#LI-GNGroup

Location: Ballerup