Global Regulatory Affairs Manager
SCA / Organisationsutvecklarjobb / Göteborg
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hela Sverige Svenska Cellulosa AktiebolagetSCA is a leading global hygiene and forest products company. The Group develops and produces sustainable personal care, tissue and forest products. Sales are conducted in about 100 countries under many strong brands, including the leading global brands TENA and Tork, and regional brands, such as Libero, Libresse, Lotus, Nosotras, Saba, Tempo and Vinda. As Europe's largest private forest owner, SCA places considerable emphasis on sustainable forest management. The Group has about 44,000 employees. Sales in 2014 amounted to approximately SEK 104bn (EUR 11.4bn). SCA was founded in 1929, has its headquarters in Stockholm, Sweden, and is listed on NASDAQ OMX Stockholm. For more information, visit
www.sca.com .
Overview
We seek a Global Regulatory Affairs Manager to provide support to our Global Hygiene Category Business.
This is a new position in the GHC organization and the person will drive regulatory questions globally supporting our Sales & Marketing organizations and Innovation teams, as well as work together with other Regulatory Managers within SCA Global Regulatory Affairs. You will be reporting to the Global Regulatory Affairs Director
It is important that the person has a solid background in a regulated area and main knowledge in the field of regulation within electronics, environmental regulations and other product related regulations, combined with a good business understanding and interest.
The ideal candidate is confident and knowledgeable in the Regulatory Affairs/Quality Assurance/Compliance area. He/She has the ability to take charge and work proactive as well as cooperate in a network to share and improve the total knowledge of SCA in his/her key competence field. The Global RA Manager needs documented experience in legislation and other regulatory demands within the specific area of competence.
This is a unique opportunity as you will contribute to build the structure and group of Regulatory Affairs using input from key stakeholders (i.e. S&M organization, R&D, QA and other colleagues) in combination with legal demands and by this strengthen our competitiveness
The Global RA organization is located in Göteborg
Main Tasks
To monitor and when/where possible influence future regulatory requirements and guidance relative to the product assortment and service offerings in the field of regulatory, environmental regulations and other product related regulations.
To support the SCA Hygiene with advice and recommendations for regulatory compliance with applicable regulation for our products mainly in the field of electronics, WEEE and RoHS and for other relevant competencies relevant for the SCA assortment
To act on behalf of the Global Regulatory Affairs Community with regulatory affairs recommendation and input primarily for global regulations and products
To bring to the attention of project managers, sponsors and the management of R&D, categories or business groups any concerns about projects or activities, risks for non-compliance with QSR, Medical Device, SW and electronic regulations or other legislation
To issue and sign relevant documents, where needed for registration of products at different sites and on behalf of SCA to official authorities
To coordinate together with Global RA community, regulatory affairs activities for products on the market and support all BU in registration, notification etc.
Required Education & Experience
University Degree in sciences or equivalent with relevance for medical health care sector, or equivalent experience in relevant practice
5 years' experience in similar functions
Experience in different well known quality methods like GAMP5, Six Sigma, SW validation techniques, FMEA, Risk management, etc.
Fluent in Swedish and English, written as well as spoken.
Good knowledge about following regulations and directives:
• ISO 13485
• ISO 14001
• Packaging and packaging waste Directive - 94/62/EC with amendments
• General Product Directive - 2001/95/EC
• Medical Device Directive - 93/42/EC Amend 2007
• Medical Device Regulation ,US - 21 CFR 820
• REACH - 1907/2006/EC
• Electronics Electrical equipment designed for use within certain voltage limits - (2006/95/EC)
• WEEE - Equipment (2012/19/EU)
• RoHS - (2011/65/EU)
• Good knowledge about corresponding regulation outside EU is preferred
Additional Information
If you have questions regarding your application, please send an e-mail to
eu.careers@sca.comIf you have specific questions regarding the job description, please call Romana Stefek-Svensson, Global Regulatory Affairs Director, 031-746 10 24
SCA kindly but firmly declines direct contact with recruiting and staffing agencies, as well as job advertising sellers.
Varaktighet, arbetstid
enligt avtal enligt avtal
Publiceringsdatum2015-08-21ErsättningSå ansöker duSista dag att ansöka är 2015-09-11
Klicka på denna länk för att göra din ansökanKontaktMarine Clappier, Talent Sourcing Specialist
marine.clappier@sca.comFöretagSCA
AdressSCA
Bäckstensgatan 5
40503 Mölndal
KontorsadressBäckstensgatan 5
Övriga kontaktuppgifter Jobbnummer 2398901
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