Global Regulatory Affairs Specialist, Certified Products
Essity AB (publ) / Kemiingenjörsjobb / Mölndal
Observera att sista ansökningsdag har passerat.
Visa alla kemiingenjörsjobb i Mölndal,
Göteborg,
Partille,
Härryda,
Kungsbacka eller i
hela Sverige Visa alla jobb hos Essity AB (publ) i Mölndal,
Härryda,
Lilla Edet,
Falkenberg,
Askersund eller i
hela Sverige Overview
This position is 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. The role shall be comprised of both strategic and operation tasks and work closely with the incontinence care, medical devices. 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.
Main task
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
Mange or collaboration sites and our request databases
Work proactively with the RA and PS manager in the group to improve way of working
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, medical devices)
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. We also see that you're a team player with good communication skills.
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.
Please apply in English online.
Essity kindly but firmly declines direct contact with recruiting and staffing agencies, as well as job advertising sellers.
#LI-Essity
Publiceringsdatum2020-01-27Så ansöker duSista dag att ansöka är 2020-02-10
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 5061723
Observera att sista ansökningsdag har passerat.