Global Regulatory Affairs Manager, Systems & Processes Medical D
Essity / Apotekarjobb / Göteborg
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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
To enable regulatory compliance, improve internal processes and support the organization in understanding the requirements of medical devices within Health and Medical Solution , we are looking for a Global Regulatory Affairs Manager.
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Main Tasks
In this position you will work together with colleagues in local Regulatory Affairs organizations in different countries with the legal responsibility for parts of the product portfolio. It is an exciting and broad role and you will work in a truly global environment.
As Global Regulatory Affairs Manager you will be responsible for ensuring regulatory compliance for current and upcoming regulations and for coordinating regulatory related tasks between different legal manufacturers within the company
You will also be responsible for the maintenance and upgrade programs of regulatory affairs IT systems from the business perspective
Establish the required awareness and processes within the company to ensure regulatory compliance with relevant global and local regulations, guidelines and standards
Coordinate with all legal manufacturers within the company to ensure that the organization develops the required capabilities and understanding in relations to regulatory requirements and implemented solutions
Keep relevant internal stakeholders informed about the regulatory landscape and if needed, raise concerns about projects or activities, risks for non-compliance with national or international product related regulations
Develop global processes and best practice processes for regulatory compliance across legal manufacturers in cooperation with RA/PS stakeholders, R&D and business units
Responsibility for the RA database where all applicable registrations and registration processes are kept. Maintain the system and ensure that information and work processes are shared between all local RA organizations. Further develop the functionality and usability of the system
Responsibility for the maintenance of the functionality in part of SAP where all technical documents related to products are kept. Improve processes and define requirements for improvement of the system
You will be responsible for the maintenance and upgrade programs of regulatory affairs IT systems from the business perspective. You will be responsible for the maintenance of the functionality in part of SAP where all technical documents related to products are kept. Improve processes and define requirements for improvement of the system.
Key Competencies
University degree in science, e.g. engineering or medical, or corresponding experience
Minimum 5 years of experience in the medical device industry working within the Regulatory Affairs or Quality Management area
Good understanding of European, US and other national medical device regulations, standards policies
Fluent in English
Experience of using and understanding requirements for IT systems for regulated industry
Experience with SAP is an advantage
We are looking for someone with a demonstrated ability to work with specialists and management. Someone who engage and influence others across disciplines, cultures and positions. 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
The position requires frequent travelling.
Please apply in English online.
For questions about the positions, please contact Hiring Manager Jenny Wennerberg +46 31 746 09 39.
Essity kindly but firmly declines direct contact with recruiting and staffing agencies, as well as job advertising sellers.
Varaktighet, arbetstid
enligt avtal enligt avtal
Publiceringsdatum2019-02-28Ersättning• .
Så ansöker duSista dag att ansöka är 2019-03-11
Klicka på denna länk för att göra din ansökanKontaktLotta Thun
FöretagEssity
AdressEssity
Mölndals bro 2
43131 Mölndal
KontorsadressMölndals bro 2
Jobbnummer 4640923
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