Regulatory Affairs Specialist Mölnlycke Health Care
Mölnlycke Health Care / Elektronikjobb / Göteborg
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Presentation
We are currently looking for a Regulatory Affairs (RA) Specialist, for a four months assignment at Mölnlycke Health Care in Gothenburg. The assignment is a temporary position at Poolia Science that will start immediately and go on until 2012-12-31.
Regulatory Affairs Specialists define and manage regulatory aspects of projects and produce Chemistry, Manufacturing and Controls (CMC) documentation for submission to Health Authorities worldwide.
Don't hesitate to apply today as selections and interviews are held on an ongoing basis.
Publiceringsdatum2012-09-10Dina arbetsuppgifterAs a Regulatory Affairs Specialist you focus will be on pre-market activities such as:
• Perform training in regulatory related topics in order to create, maintain and improve the understanding of regulation for medical devices and other products.
• Consult with regional regulatory directors and advice other internal customers in order to gain and support product approval.
• Keep the internal data bases up to date to maintain regulatory status up to approval of CMC documentation supplied by Operations to Global Regulatory Affairs.
• Use your regulatory knowledge to ensure a high standard of the delivery of applications of global CMC regulations and guidance.
• Lead several different RA projects
• Support R&D and marketing projects (Serve as a Regulatory Affairs representative in R&D and marketing projects)
The role offer opportunities to work with global networks in USA and Japan.
Utbildning/erfarenhet
You have a University degree, or equivalent, in Chemistry, Biology, Engineering or a related subject. You have experience from Medical Device/Pharmaceutical Companies for at least five years and Regulatory Affairs for at least two years.
As a person you have the ability to learn and keep up to date with new and changing regulations, team working skills, project management skills and IT Software skills. You pay attention to details and concern for standards and accuracy. You are used to work in an international environment and possess good communication skills in business English
You are a good planner and organizer and have the ability to establish fruitful relationships and maintain networks as you will be the link between R&D and marketing projects.
Förmåner
We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.
As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.
Företagsbeskrivning
Poolia Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden's leading pharmaceutical and life science companies. So whether you're interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.
Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you're looking for a world of exciting assignments and new contacts, you'll like being a consultant.
Sluttext
Please apply by registering your CV here on our website. Click on the "Ansök" button to the right of this advertisement. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail adress is registered.
Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.
Så ansöker duSista dag att ansöka är 2012-09-24
Ange följande referens när du ansöker: 32914
Ansökan kan tyvärr inte göras via e-post.
Klicka på denna länk för att göra din ansökanKontaktFöretagMölnlycke Health Care
AdressMölnlycke Health Care
Jobbnummer 1336156
Observera att sista ansökningsdag har passerat.