Global Regulatory Specialist
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Ballerup
Want to become the regulatory expert within a major region?
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.
“This is a great opportunity for you to run your own territory as part of a small and friendly team where there’s lots to learn and room to grow,” says Vice President, Quality Assurance and Regulatory Affairs, Amarjit Gill.
We transform lives through the power of sound
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.
Ensure smooth market access for brand-new products
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:
Collaboration is key
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.
Experience with regulatory affairs and medical devices
To succeed in this role, you are a self-starter who is up for running your own territory directly with the top leaders of the countries your markets cover. Moreover, you:
Would you like to know more?
To apply, use the ‘APPLY’ link no later than 9th October, 2020. 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 VP QA & RA Amarjit Gill on + 45 60 34 00 39.
#LI-Resound
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.
“This is a great opportunity for you to run your own territory as part of a small and friendly team where there’s lots to learn and room to grow,” says Vice President, Quality Assurance and Regulatory Affairs, Amarjit Gill.
We transform lives through the power of sound
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.
Ensure smooth market access for brand-new products
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
Collaboration is key
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.
Experience with regulatory affairs and medical devices
To succeed in this role, you are a self-starter who is up for running your own territory directly with the top leaders of the countries your markets cover. Moreover, you:
- Have experience from a role in regulatory affairs in the medical device industry
- Have knowledge of ISO 13485 and other standards, and you have experience with completing medical device submissions
- Have strong English communication skills both in speech and writing
- Have an advantage if you have a technical background such as an engineering degree – allowing you to understand the technical documentation you handle
Would you like to know more?
To apply, use the ‘APPLY’ link no later than 9th October, 2020. 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 VP QA & RA Amarjit Gill on + 45 60 34 00 39.
#LI-Resound
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 17.9.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Ballerup
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