Regulatory affairs manager

Poolia Uppsala / Biomedicinjobb / Uppsala
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Poolia Uppsala
Presentation
On behalf of one of our clients, we are currently looking for a regulatory affairs manager for a temporary position. You will be placed in Uppsala and the position is fulltime.
Selections and interviews are held on an ongoing basis. We welcome your application.

Publiceringsdatum
2010-09-30

Dina arbetsuppgifter
As a regulatory affairs manager you will be responsible for the following tasks:
• preparation and maintenance of 510(k) files for the company's products
• preparation of design dossiers for review by a Notified Body
• reviewing and approving product changes in accordance with regulatory guidelines and the company's quality routines
• reviewing and approving advertising and promotional materials for regulatory implications
• ensuring compliance with, and knowledge of, international regulations, guidelines and standards
• handling vigilance reporting
• contributing with regulatory knowledge in development and production when required.
Utbildning/erfarenhet
You have a bachelor's degree in the biomedical field or equivalent. You also have previous international medical device submissions, filed and proved. It is also required that you have experiences working with ISO 13485, QSR and GMP. In addition, you are also fluent in English and Swedish and you know how to write in a technical way.
Furthermore, it is an advantage if you have held previous positions in regulatory affairs, quality assurance or clinical research in life science.
As a person you are analytical, precise and thorough. You have a talent for critical thinking and would be described as a skilled problem solver.
Företagsbeskrivning
Poolia is a leading Recruitment Consultancy, located in more than 20 cities in Sweden, Denmark, Finland, Germany and the United Kingdom. Poolia performs temporary staffing and permanent placement assignments within Accounting & Control, Banking & Finance, IT & Technology, Office, Human Resources, Payroll, Engineering, Sales & Marketing, Law and Life Science. In 2007 net sales totalled 134 million Euro. Poolia was founded in 1989 and has today more than 2.000 employees.
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 du
Sista dag att ansöka är 2010-10-14
Ange följande referens när du ansöker: 24312
Ansökan kan tyvärr inte göras via e-post.
Ansökan sker via företagets webbplats.

Kontakt
Företag
Poolia Uppsala

Adress
Poolia Uppsala

Jobbnummer
744230

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