Regulatory Affairs Specialist

SHL Group AB / Sjukhusteknikerjobb / Nacka
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SHL Group RA has the regulatory responsibility for SHL's extensive product portfolio within medical devices and drug-device combination products. You will be organized under the QA/RA department at SHL Sweden and alone or together with regulatory colleagues located in SHL Taiwan and/or SHL USA you will contribute to project development. You will also be responsible for supporting the organization and/or SHL's customers with worldwide regulatory submissions.

Your responsibilities will include (but not limited to):

• Support in filing marketing applications in Europe (worldwide filing experience would be an asset for this role) in line with the company strategy and authorities requirements
• Work with license maintenance
• Monitor regulatory requirements worldwide (particularly EU and USA)
• Provide administrative support to regulatory projects and activities
• Manage both Medical Device and drug-device combination product submissions

Qualifications:

• You have a relevant University Degree
• You have Regulatory Affairs experience in the Medical Device (or at least Pharmaceutical) industry
• You are open-minded and willing to adapt to differences
• You enjoy working with others in a collaborative way
• You posses strong communication skills; fluency in English both verbal and written is required.
• International experience would be an asset for this role

See www.shl-group.net for information regarding SHL Group

You may also contact Kamran Kaviani, Department Manager,
• 46 8 462 18 14

Publiceringsdatum
2014-11-17

Arbetstider och omfattning
Tillsvidare
Heltid

Ersättning
Fast lön

Så ansöker du
Sista dag att ansöka är 2015-01-17
Ange följande referens när du ansöker: RA-2014
Ansökan kan skickas till e-postadress: kamran.kaviani@shl-group.com

Kontakt
Kamran Kaviani

Företag
SHL Group AB

Adress
SHL Group AB
Box 1240
13128 Nacka Strand

Kontorsadress
Augustendalsvägen 19
Nacka Strand
Visa på karta

Övriga kontaktuppgifter
Telefonnummer: 08-4621800
Faxnummer: 08-4621890

Jobbnummer
2069197

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