Quality & Regulatory Specialist
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.
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 part of the quality management system and supporting the product development teams as well as marketing and sales organization with regulatory input. This includes but is not limited to;
• Establishing Technical File documentation
• Communicating with regulatory authorities and preparing product registrations worldwide
• Leading risk management activities
• Ensure that product labelling is incompliance with product claims
• Complaints and CAPA handling
• MDR and vigilance reporting
• Preparing, implementing and supervising the compliance of quality procedures
• Perform internal audits and audits of subcontractors and distributors
• 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 5 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, a good understanding of Danish is desired
• 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 Senior Director of Quality Assurance & Regulatory Affairs Karolin Isberg Jernby at +46 31 748 61 53. Please send in your application to
kai@oticonmedical.se before October 10, 2012. We look forward to receiving your application.
Publiceringsdatum2012-09-11Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2012-10-11
Ansökan kan skickas till e-postadress:
kai@oticonmedical.seFöretagOTICON MEDICAL AB
AdressOTICON MEDICAL AB
EKONOMIVÄGEN 2
43633 ASKIM
KontorsadressEKONOMIVÄGEN 2
ASKIM
Övriga kontaktuppgifterTelefonnummer: 031-7486100
E-postadress:
info@oticonmedical.com Jobbnummer 1336538
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