Quality assurance and regulatory affairs special
Oticon Medical AB / Organisationsutvecklarjobb / Göteborg
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hela Sverige Visa alla jobb hos Oticon Medical AB i Göteborg We are looking for an internationally oriented quality assurance and regulatory affairs specialist to support or fast growing business and international expansion. We have an opening due to maternity leave with the possibility to become a fixed member of the quality and regulatory team.
Oticon Medical is a small Gothenburg based company. Being part of the Danish William Demant Holding group Oticon Medical work in close cooperation with Oticon A/S one of the world’s largest hearing aid companies. As a key member of a small energetic team you will be responsible for maintaining the quality management system and supporting the product development teams as well as marketing and sales organization with regulatory input. This includes;
• Establishing products Technical File
• Reviewing marketing material considering product claims
• Communicate with regulatory authorities and preparing regulatory submissions
• Leading risk management activities
• Handling complaints
• Preparing, implementing and supervising the compliance of quality procedures
• Planning, documentation and monitoring of clinical trails
We offer you the opportunity to join a young, enthusiastic start up team focused on the continued growth and expansion of our company. You will be working in a team but largely independently.
Your qualifications
• Minimum 3 years of experience in working with quality and regulatory issues in a medical device company
• Thorough understanding of MDD, ISO 13485 and QSR
• Good communication skills both written and spoken with Swedish and English
• You are an outgoing and positive team player who can work structured and independently
• You understand the challenges of working in a start-up environment
If you have questions about this position please contact our Quality & Regulatory manager Karolin Isberg at +46 31 748 61 53. Please send in your application to
kai@oticonmedical.com before November 20, 2009.
Publiceringsdatum2009-11-06Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2009-11-20
Ansökan kan skickas till e-postadress:
kai@oticonmedical.comFöretagOTICON MEDICAL AB
AdressOTICON MEDICAL AB
EKONOMIVÄGEN 2
43633 ASKIM
KontorsadressEKONOMIVÄGEN 2
ASKIM
KontaktuppgifterTelefonnummer: 031-7486100
Faxnummer: 031-687756
Jobbnummer 532839
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