QA/RA to Glooko
PS Partner / Elektronikjobb / Göteborg
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hela Sverige Want to join a fast-paced company with a mission to improve the life of people living with diabetes? Glooko/diasend® is a market leading solution that simplifies life with diabetes by optimizing diabetes data management.
Our comprehensive and market leading solutions involve uploading, storing and analyzing data from a clear majority of the diabetes devices currently available on the global market - allowing patients and caregivers easy access, understanding and sharing the same information. This equals highly valued support for people living with diabetes during, as well as in-between, doctor visits and makes the work of diabetes-coaches around the world much more efficient and accurate.
Over the last few years we have grown quickly, and we are now at the point of our next big phase of expansion, aiming at establishing presence with new exciting products in several markets. To get there, the search for a number of new talented and driven co-workers has begun.
We are a global company with 130+ employees located in the San Francisco Bay Area, Chicago, London and Gothenburg - currently serving 7000 diabetes clinics in 23 countries across 15 languages, impacting the lives of tens of millions of people with diabetes on a daily basis.
In our brand new Gothenburg office, close to Liseberg, (yes - you will have Lisebergskortet as an employee benefit) we are currently 35 co-workers who are responsible for sales, customer support and marketing for all international markets, except North America. We also have a dedicated team of engineers that works with technical development for all global markets.
Intrigued?
We 're looking for a QA/RA Manager.
As a QA/RA Manager you will provide both regulatory and quality assurance support trough out the lifecycle of our web-based Diabetes Data Management platform. You will also be responsible for registration of our products within the EMEA/APAC region and work closely with the organisation to make sure that they comply with the regulatory demands within active markets.
You will be responsible for these key areas for the products that fall under your responsibility:
• Be our regulatory expert in product development projects and be proactive in communicating potential impact of regulatory activities on marketing plans
• Create, review and compile documentation and maintain technical files
• Address European regulatory requirements by vigilance reporting
• Take part in regulatory strategy and planning, by supporting project teams with regulatory compliance advice trough product development
• Ensure regulatory submission and related activates by preparing and managing submission processes to gain new or modified product approval and maintain product licenses for current products.
Experience and competence requirements
• Relevant education, e.g. Scientific, Engineering or Healthcare or experience in regulatory affairs in medical device industry.
• 3+ years of working experience in a similar role.
• In depth understanding of the regulatory framework as well as in depth understand of the process of quality assurance
• Excellent in English and Swedish, both in speech and writing, as your communication skills will be vital in discussions with clients and offshore colleagues.
If you already have knowledge or interest in health and diabetes, that is an advantage - but it is not required. Submit your application now if you want to help simplify life for everyone with a connection to diabetes!
What can Glooko/Diasend offer you?
Glooko/Diasend offer a very stimulating international challenge in an established, stable international company. The global business responsibility in this role offers the right candidate great development opportunities - and all the excitement that comes with working at a Silicon Valley based company. We are looking for someone who wants to be a part of our organization for the future with great influence and great responsibility.
Is this you? If so, don't hesitate to apply! For inquiries please contact recruitment consultant Anna Petersson
anna.petersson@pspartner.se or Elina Röckner
elina.rockner@pspartner.se.
For more information
www.glooko.comVaraktighet, arbetstid
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Publiceringsdatum2018-10-08ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-12-06
Klicka på denna länk för att göra din ansökanFöretagPS Partner
AdressPS Partner
Första Långgatan 18
41328 GÖTEBORG
KontorsadressFörsta Långgatan 18
Jobbnummer 4389885
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