Regulatory Affairs Specialist Medical Devices
Essity / Maskiningenjörsjobb / Göteborg
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hela Sverige EssityEssity is a leading global hygiene and health company dedicated to improving well-being through our products and solutions, essentials for everyday life. The name Essity stems from the words essentials and necessities. Our sustainable business model creates value for people and nature. Sales are conducted in approximately 150 countries under the leading global brands TENA and Tork, and other strong brands, such as Jobst, Leukoplast, Libero, Libresse, Lotus, Nosotras, Saba, Tempo, Vinda and Zewa. Essity has about 48,000 employees and net sales in 2017 amounted to approximately SEK 109bn (EUR 11.3bn). The headquarters is located in Stockholm, Sweden, and the company is listed on Nasdaq Stockholm. More information at
www.essity.com. Overview
We are currently going through exciting changes within Regulatory Affairs and Product Safety at Essity which enables us to bring in additional passionate and business-driven colleagues around the world! Following Essity 's strategic move into healthcare and its acquisition of BSN medical, a leading medical device company, as well as the growing regulatory demand also in hygiene products, we have now created a dedicated, global Regulatory Affairs and Product Safety organization within our Business Unit Global Hygiene Category. The Global Hygiene Category leads Essity's hygiene brand portfolio and delivers brand development and innovation within the product areas of Incontinence Care, Baby Care, Feminine Care, Consumer Tissue and Hygiene Solutions.
To be part of the Global Regulatory Affairs and Product Safety team within Systems & Processes, we are now looking for a globally acting Regulatory Affairs Specialist for our Medical Devices.
The position is located in Gothenburg.
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Main Tasks
The purpose of the role is to ensure that technical documentation and product requirements is in accordance with internal regulatory and quality processes. This is done in order to ensure that we obtain and maintain market authorization internationally under Medical Device Directive and upcoming Medical Device Regulations. The role works closely with the Regulatory Affairs Manager and the Product Safety Specialists.
To support the compilation of technical product files necessary for registration of assigned products within medical devices
To assist with the collection of regulatory documentation and statements necessary for registrations/notifications both locally and internationally including administration of the cases.
Perform notifications in Sweden and on other markets
To support with the preparation of regulatory documentation required for the manufacture, distribution and marketing of products, in line with applicable product regulations
To assist with the collection of regulatory documentation for submission of tenders both locally and internationally
To establish and maintain a regulatory authorization overview for registration of the assigned product portfolio within medical devices
To be the company's day to day point-of-contact with regulatory bodies within medical devices
Key Competencies
Bachelor's degree in chemical, technical or pharmaceutical studies is preferred but not a requirement
Minimum 5 years of relevant work experience (e.g. regulatory, product safety)
Advanced experience in documentation
Business minded and result driven
Excellent communication skills with different internal and external stakeholders
Excellent English skills, written as well as spoken
To be successful in this role, we believe you have a business curiosity and comprehensive understanding of how the whole value chain works. We expect holistic thinking, i.e. the ability of taking a broad stakeholder perspective and connecting business opportunities with a high regulatory and product safety compliance standard.
Additional Information
At Essity, our ambition is to increase health and hygiene standards across the world. To do this, we depend on motivated, competent and high-performing employees.
Please apply online.
Essity kindly but firmly declines direct contact with recruiting and staffing agencies, as well as job advertising sellers.
Varaktighet, arbetstid
enligt avtal enligt avtal
Publiceringsdatum2018-04-13Ersättning•
Så ansöker duSista dag att ansöka är 2018-05-04
Klicka på denna länk för att göra din ansökanKontaktÅsa Linder
FöretagEssity
AdressEssity
Mölndals bro 2
43131 Mölndal
KontorsadressMölndals bro 2
Jobbnummer 4082320
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