Regulatory Affairs Manager
Maquet AB / Elektronikjobb / Stockholm
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hela Sverige Every day, Getinge Group products contribute to saving lives and ensuring excellent care. All across the world, our people make a huge difference for patients, healthcare professionals and societies. And we are very proud of that.
With more than 6,300 employees and ¬1.5 billion in annual revenue, Maquet designs, develops and distributes innovative therapy solutions and infrastructure capabilities for high-acuity areas within the hospital.
We are now recruiting a Regulatory Affairs Manager to Maquet Critical Care in Solna.
The position
The purpose of the role is to be part Maquet Critical Care's (MCC's) Regulatory Affairs and Quality Assurance team for its product areas (e.g. Ventilation, Anesthesia, Accessories and Monitoring) and to support internal and external customers. This position offers a great opportunity to work with and improve world class med-tech products in a challenging regulatory environment with high standards and ambitions!
Among your main responsibilities and tasks will be:
• Establish documentation for CE-marking, i.e. Technical File, Essential Requirements Checklist and Declaration of Conformity
• Develop and submit applications to US and Canada for market clearance/ approval
• Support our sales companies worldwide to apply with regulatory submissions in there countries
• Support to the R&D and Market Introduction projects
• Support to Product Maintenance
• Continuous improvement
International travel is expected on an occasional level.
The ideal candidate
As ideal for the position you have a minimum of five years' experience from the medical device industry. Experience from RA/QA (i.e QSR, MDD, ISO13485, IEC60601 and audit training) is beneficial. Further, you have a Master degree in a relevant field together with excellent skills in English - both written and spoken. As a person you are action-orientated, driven and independent with a great amount of integrity. You have a coherent, challenging and process-oriented attitude and an excellent ability to communicate and collaborate with both internal and external stakeholders.
Application
Are you interested in becoming part of an international and market leading medical technology company whose products make huge difference for patients, healthcare professionals and societies all around the world? Maquet offers a great opportunity to make a difference in a global and dynamic environment with strong ethics and morals! Our office is centrally located in Solna and offers great communications!
Welcome with your application via ATS link no later than 2nd of June if you are interested in the position. You are also welcome to contact Lars Berkén at +46-70-782 75 08 if you have questions.
Maquet | The Gold Standard.
Varaktighet, arbetstid
Heltid Tills vidare
Publiceringsdatum2015-05-13ErsättningFast
Så ansöker duSista dag att ansöka är 2015-06-02
Klicka på denna länk för att göra din ansökanFöretagMaquet AB
AdressMaquet AB
Röntgenvägen 2
17154 Solna
KontorsadressRöntgenvägen 2
Jobbnummer 2294047
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