Global Regulatory Specialist
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Ballerup
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. Their ambitious 150-year journey has taken them from telegraph cables to radio waves and intelligent audio engineering. To celebrate this anniversary, GN look to their unique competences within medical, professional and consumer audio solutions to help them continue to transform lives through the power of sound.
GN was founded with a truly innovative and global mindset. Today, they honor that legacy with world-leading expertise in the human ear, sound, wireless technology, miniaturization and collaborations with leading technology partners.
Through its ReSound, Beltone and Intertone brands, GN Hearing provides advanced hearing aid solutions to make life sound better. And your new team – the Market Access team – plays a key role in ensuring that our products can reach our users across the world.
As part of the Market Access team at our HQ in Ballerup, you will join 3 global regulatory specialists like yourself – covering the Asian, European and the American (the US, Canada, and South America) regions. Thus, you will work very independently with your own territory, but you all have the benefit of sharing knowledge and working in a team of experts.
Moreover, you will need to collaborate closely with R&D and country managers to ensure that we listen to and challenge each other. Ultimately, to ensure smooth market access and transform the hearing aid industry.
The team is international; hence you will work alongside colleagues from Russia, Denmark, Poland and Sweden.
Team members work highly independently, however strong alignment in the team is needed especially on the large base programs and general knowledge sharing in order to constantly improve one's skills.
Teamlead Pernille is described as a listener, a strong sparring partner, understanding what needs to be done, and highly encouraging of teamwork.
As our new global regulatory specialist, you will become a vital link between R&D and our markets as you ensure that we can provide first-class hearing care across the region assigned to you.
Bridging product development with the commercial organization, you will become the regulatory spokesperson covering your own region. For every new product launch, you are the one completing or overseeing regulatory submissions and providing the country managers with the technical information and official approvals they need to market the product. Your main tasks will be to:
GN was founded with a truly innovative and global mindset. Today, they honor that legacy with world-leading expertise in the human ear, sound, wireless technology, miniaturization and collaborations with leading technology partners.
Through its ReSound, Beltone and Intertone brands, GN Hearing provides advanced hearing aid solutions to make life sound better. And your new team – the Market Access team – plays a key role in ensuring that our products can reach our users across the world.
As part of the Market Access team at our HQ in Ballerup, you will join 3 global regulatory specialists like yourself – covering the Asian, European and the American (the US, Canada, and South America) regions. Thus, you will work very independently with your own territory, but you all have the benefit of sharing knowledge and working in a team of experts.
Moreover, you will need to collaborate closely with R&D and country managers to ensure that we listen to and challenge each other. Ultimately, to ensure smooth market access and transform the hearing aid industry.
The team is international; hence you will work alongside colleagues from Russia, Denmark, Poland and Sweden.
Team members work highly independently, however strong alignment in the team is needed especially on the large base programs and general knowledge sharing in order to constantly improve one's skills.
Teamlead Pernille is described as a listener, a strong sparring partner, understanding what needs to be done, and highly encouraging of teamwork.
As our new global regulatory specialist, you will become a vital link between R&D and our markets as you ensure that we can provide first-class hearing care across the region assigned to you.
Bridging product development with the commercial organization, you will become the regulatory spokesperson covering your own region. For every new product launch, you are the one completing or overseeing regulatory submissions and providing the country managers with the technical information and official approvals they need to market the product. Your main tasks will be to:
- Continuously assess market requirements to make sure you are up to speed and ready for new product launches
- Plan, prioritize, coordinate and complete technical submissions and gain approvals from relevant official agencies
- Engage with technical colleagues in R&D and third-party test houses to gather product documentation and evidence
- Support, train and communicate with country managers about market access processes and cases, including 10-15 travel days a year across your region
- Provide support to inspections and audits
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 29.1.2021, men kan have været deaktiveret og genaktiveret igen.
- Øvrige
- Ballerup
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|---|---|
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