Homologation Specialist

Do you have an eye for optimizing processes because you enjoy when everything is done efficiently and by the book? And do you want to be part of a new team that already has a great working culture in place?

Then use your expertise within homologation in the medical device industry to make sure our advanced hearing aids make life sound better for people across the world. As our new homologation specialist, you will ensure that we have the approvals and documentation we need to sell our products in our global markets.

We transform lives through the power of sound
Through our ReSound, Beltone and Interton brands, GN Hearing provides best-in-class hearing aid solutions. In Global Partner Sales (GPS), we sell our solutions through local distributors in 70+ countries. And to do so, we need to ensure that every single product follows market-specific legislation.

You will be a part of our Product Team of 8 people with different nationalities. Since the team was established in September last year, there is still plenty of room for you to leave your mark and help us develop our working processes. We already have a strong collaborative culture that we look forward for you to join.

“Even though we were formed during the pandemic, we have still made it a priority to go for walks and have breakfast together every Friday. Professionally, we have a very open and honest communication style, and we are good at actively seeking and giving feedback and help,” explains Head of GDS Product Team Mariana Roslyng-Jensen.

Become an expert on registration of our products in all distributing countries
It is your main responsibility to ensure that we provide the necessary documentation to get the products of all three brands registered by the local authorities primarily via our distributors. This documentation could for example be CE-certification, samples, packaging and proof that the product has been tested. Since the complexity of the requirements differ between the countries, prioritizing our efforts is an important part of your job.

You will be taking on the role as field expert and take care of the most complicated countries. Your closest partners will be our homologation assistant and student assistant, who will help you retrieve the documentation in Agile and SharePoint. Moreover, you will collaborate with the distributors, sales organization, product management and our Customer Care department.

Some of your most important tasks will be to:

• Plan and coordinate product registrations for GPS’ 70+ markets
• Coordinate end-to-end complex registration in cooperation with Market Access
• Assess the possible impact on product registrations if a change on a product is suggested
• Monitor and update national product registration requirements and keep distributors up to date
• Work strategically to smoothen our processes
• Participate in audits where required

Experience with regulatory processes within medical devices
You understand the need to live up to the regulatory requirements from our markets. Here, your sharp eye for detail will be needed. At the same time, you thrive in the role as gatekeeper where your ability to say no is important to make sure that we do not do anything as a business that puts our registrations – and thereby sales – at stake.

We furthermore imagine that:

• You preferably have a master’s degree, perhaps as an engineer. You are good at navigating and optimizing different processes and familiarizing yourself with new, complicated material
• You have 3+ years’ experience working with homologation and regulations from the medical devices industry
• You speak and write English fluently – Danish is not a prerequisite

 Would you like to know more?
To apply, use the ‘APPLY’ link no later than 4. May 2021. Applications are assessed on a continuous basis, which is why we encourage you to send your application as soon as possible. 

If you want to know more about the position, you are welcome to contact Head of GPS Product Team Mariana Roslyng-Jensen on + 45 4575 1685.

Please write in your application that you've seen the job at Jobfinder.