Regulatory Affairs Specialist

GN Hearing
Ballerup - Denmark
Published: February 26, 2019
Are you motivated by working with detailed documentation, delivering high quality in a dynamic international environment? Then you may be our new Regulatory Affairs Specialist.

Transforming lives through the power of sound

The GN Group is a global leader in intelligent audio solutions that let you hear more, do more and be more than you ever thought possible. Our unique portfolio of medical, professional & consumer solutions – and the deep research & development expertise behind this range of products gives our brands unprecedented advantages in the MedTech hearables and intelligent audio field.

Welcome to the Regulatory Affairs Team
You will work in our Regulatory Affairs organization in GN Hearing A/S in a team of highly specialized and dynamic people with diverse competences working across our global organization.

In the Regulatory Affairs team we are part of the product development programs and in the period from first prototype to launch of the product, we are responsible for the operational part of the product approval process. We plan, co-ordinate and send the required documentation to relevant stakeholders. We support more than 90 countries including our subsidiaries regarding product approvals and certifications.

As our new Regulatory Affairs Specialist, you will be working with various aspects of regulatory affairs tasks especially within the area of product approvals. More specifically you will:

• Plan, coordinate and execute product registrations for GNH R&D programs
• Coordinate end-to-end approval related activities with appointed 3rd party test houses
• Monitor national product registration requirements.
• Interface with and daily support to R&D programs, GNH subsidiaries and Global Distributor Sales
• Conduct training to key stakeholders in GNH and subsidiaries
• Maintaining and development regulatory processes
• Support inspections and audit

Flair for details and focus on completing tasks
As a person you have a good energy and drive. You are pro-active, persistent and positive when reaching out to your colleagues which is important in the solution of the tasks. You have an eye for details, work structured, have a good overview of different tasks/deadlines and know what it takes to drive global registration tasks.

We imagine that you:
• Hold a relevant bachelor's or master's degree
• Have minimum. 2-3 years of experience from similar regulatory affairs position. Preferably from the MedTech industry
• Are a team player with great collaboration skills, but also good at working independently with your own tasks
• Proven competences in gathering, analyzing and organizing complex information
• IT savvy and know your way around MS Office including MS Outlook, Word, Excel, MS SharePoint and Adobe as well ability to work in customized IT tools
• Have the flexibility to travel 10-15 days a year

Would you like to know more?
Use the ‘APPLY’ bottom no later than 29 March 2019. 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, Cathrin Inge Hansen, Project Manager Regulatory Affairs +45 45 75 17 59

About us
The GN Group is a global leader in intelligent audio solutions that let you hear more, do more and be more than you ever thought possible. Our ambitious 150-year journey has taken us from telegraph cables to radio waves and intelligent audio engineering. To celebrate our anniversary, we look to our unique competences within medical, professional and consumer audio solutions to help us continue to transform lives through the power of sound.

GN was founded with a truly innovative and global mindset. Today, we honor that legacy with world-leading expertise in the human ear, sound, wireless technology, miniaturization and collaborations with leading technology partners. GN's solutions are marketed by the brands ReSound, Beltone, Interton, Jabra and BlueParrott in 100 countries. Founded in 1869, the GN Group employs more than 6,000 people and is listed on Nasdaq Copenhagen (GN.CO).

Visit our homepage – and connect with us on LinkedIn, Facebook and Twitter.

For the purpose of processing your job application, GN will process your personal data. We encourage you not to provide us with sensitive information (e.g. racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, health information or sexual orientation) about yourself. Your application will be transferred to the local GN office posting this job. For information about how GN processes your personal data, please read our » privacy policy.