Global Regulatory Affairs Manager Incontinence Care
Essity AB (publ) / Kemiingenjörsjobb / Mölndal
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hela Sverige 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 Certified products
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
What We Can Offer You
At Essity, we believe every career is as unique as the individual and empower employees to reach their full potential in a winning culture motivated by a powerful purpose.
Collaborative and caring Work Environment | Empowerment | Job Impact | Work with a Powerful Purpose | Individual Learning and Development | Health & Safety | Social Responsibility | Innovation
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.
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Working at Essity is not just a career; it is a chance to directly make the world a healthier, more hygienic and safer place. With impactful innovations coupled with sustainable solutions, we strive to reach more people every year with the necessary and essential solutions for well-being.
Publiceringsdatum2020-01-27Så ansöker duSista dag att ansöka är 2020-02-26
Klicka på denna länk för att göra din ansökanAdressEssity AB (publ)
Mölndals bro 2
43131 Mölndal
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Essity AB (publ) (org.nr 556325-5511)
Mölndals bro 2 (
visa karta)
431 31 MÖLNDAL
Arbetsplats Essity Hygiene and Health AB
Jobbnummer 5061730
Observera att sista ansökningsdag har passerat.