Global Regulatory Affairs Manager Incontinence Care
Essity / Logistikjobb / 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 and support the organization in understanding the requirements of the medical device products related to incontinence care developed, produced and delivered across Essity we are looking for a Global Regulatory Affairs Manager. The role shall be comprised of both strategic and operation tasks and work closely with the incontinence care, medical devices.
The focus will be on securing corporate procedures regarding technical file/DHF, compliance in our Innovation projects, secure proper document handling, provide training in regulatory affairs cross the business. The Regulatory Affairs Manager is responsible for product projects related RA with regards to interpretation of MDD/MDR for Incontinence care cross all categories with focus on USA and Canada regulation, but also other relevant standards/directives/guidelines and to get them known in the organization and applied. Additionally, the role also entails all cross over support, medical device expertise, supporting in global processes and procedures.
The position is based in Gothenburg and the person will report directly to the Global Regulatory Affairs/Product Safety Director for Incontinence Care.
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Main Tasks
Make the organization aware of future regulatory requirements and guidance relative to the product assortment and service offering regarding MD related to incontinence mainly US.
Actively support that registrations can be submitted and interpret the registration criteria in order to choose the most favorable way for access to market
Develop global procedures and best practices for compliance of Regulatory Affairs related to incontinence care within Essity
To actively affect relevant stakeholders i.e. project managers, sponsors and the management of R&D, categories or business groups, in projects or activities to be aware of potential risks for non-compliance with medical device regulations
Be the counterpart to authorities regarding vigilance and handling of SAE and reporting to competent authorities on behalf of GRA Director
Actively participate in trade associations or other organizations to represent agreed Essity positions and strategy related to Medical Devices
To issue and sign relevant documents, where needed for registration of products at national official authorities in global markets
See to that the category is up to date with current worldwide regulation and legislation within the organization
Key Competencies
Experience with relevance for medical health care sector, or equivalent within relevant practice
Minimum 5 years technical experience in Regulatory Affairs
Understanding of medical device directives/regulations, and related standards and guidelines
Have been doing registration for MD at FDA like 510(k) etc
Ability to work in an international setting & represent Essity in a professional manner
Ability to influence others internally & externally
Excellent communication skills and fluency in English
To have a business expertise and understand strategic business impact of regulations and interaction between all directives and regulations
Problem solving - you must have the ability to handle topics with multiple external stakeholders coming to a common decision
To work with coordination cross all competence areas and functional areas and act as a coordinator to harmonize way of working
Additional Information
If you have any questions please contact Romana Stefek-Svensson, Global Regulatory Affairs/Product Safety Director at +46 31 746 10 24.
Essity kindly but firmly declines direct contact with recruiting and staffing agencies, as well as job advertising sellers.
Varaktighet, arbetstid
enligt avtal enligt avtal
Publiceringsdatum2019-02-20Ersättning•
Så ansöker duSista dag att ansöka är 2019-03-12
Klicka på denna länk för att göra din ansökanKontaktLotta Thun
FöretagEssity
AdressEssity
Mölndals bro 2
43131 Mölndal
KontorsadressMölndals bro 2
Jobbnummer 4624193
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