Regulatory Affairs Specialist

Thermo Fisher Scientific / Administratörsjobb / Uppsala
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Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermoscientific.com/phadia

Regulatory Affairs Specialist
Thermo Fisher Scientific Immuno Diagnostic Division (IDD) is looking for a Regulatory Affairs Specialist with experience within the IVD field, for our Global Regulatory Affairs team placed at our headquarters in Uppsala, Sweden. You will work with varying tasks, both independently and in teams, internally and with external partners.

The main responsibilities will be to:
• Actively participate in product registration projects on defined global markets.
• Compile and submit required documentation to obtain registration licenses.
• Communicate with internal and external partners in specified countries.
• Participate in product development as regulatory counterpart.
• Review and approve product registration documentation.
• Contribute to improved routines and processes for the Global Regulatory Affairs team.

Qualifications:
• 2-4 years experience in global IVD product registrations and/or deep knowledge in IDD product development, product designs and their clinical use.
• Experience of review and assessment of product performance data originating from e.g. development and verification reports.
• Fluent in Swedish and/or English, both spoken and written.
• University science degree or similar.
To fit the position you should have a good sense of structure, clarity and ability to plan the work. You should have a positive attitude, be service-minded and a good communicator. The Global Regulatory Affairs team will provide excellent possibilities for qualified discussions and personal development within the field.
For further information please contact:

• Lotta Bitzén- Hermodsson, Director Global Regulatory Affairs + 46 18 16 51 53
• Håkan Olsson, Director HR + 46 18 16 53 46

Publiceringsdatum
2015-04-02

Arbetstider och omfattning
Tillsvidare
Heltid

Ersättning
Fast månads- vecko- eller timlön

Så ansöker du
Please send your application with CV and marked reference no. 30 to hr.idd@thermofisher.com . We need your application before April 19, 2015.
Ansökan kan skickas till e-postadress: hr.idd@thermofisher.com

Kontakt
Lotta Bitzén- Hermodsson, Director Global Regulatory Affairs + 46 1816 5153
Håkan Olsson, Director HR + 46 18 16 53 46

Företag
Thermo Fisher Scientific

Adress
Thermo Fisher Scientific
Box 6460
75137 UPPSALA

Kontorsadress
Rapsgatan 7P

Övriga kontaktuppgifter
Telefonnummer: 018-165000
E-postadress: hr.idd@thermofisher.com

Jobbnummer
2232691

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