Regulatory Affairs Contractor Senior
Poolia Sverige AB / Kemiingenjörsjobb / Stockholm
Observera att sista ansökningsdag har passerat.
Visa alla kemiingenjörsjobb i Stockholm,
Solna,
Lidingö,
Sundbyberg,
Danderyd eller i
hela Sverige Visa alla jobb hos Poolia Sverige AB i Stockholm,
Solna,
Lidingö,
Sundbyberg,
Danderyd eller i
hela Sverige RELEVANT INFORMATION:
Occupancy: 100%,
Start date: 01.03.2021
Initial duration: 6 months
This role is to be based in Sweden, Uppsala/Stockholm.
MAIN TASKS FOR THE ROLE:
• Prepare and assemble regulatory submissions for achieving registrations of Ophthalmic Viscoelastic Devices (OVDs) in EU
• Manage documents submitted in document management system
• Prepare Regulatory Impact assessments for EU
• Participate in design control of new or revised products developed or manufactured in Uppsala.
• Compile and maintain Technical files according to MDD/MDR
• Provide RA support during audits
• Support global RA teams with expert guidance
• Registrations and renewals
QUALIFICATIONS AND EXPERIENCE
Education:
• Bachelor's degree or equivalent training in life sciences or medical device engineering or a long-term healthcare industry background is required.
• Experience with medical device submissions required.
• Minimum of 5 years of professional experience within Regulatory Affairs.
• Solid understanding of national medical device regulatory requirements & procedures to obtain market access.
• CE marking experience with NBs required.
Varaktighet, arbetstid
Heltid Visstid, mer än 6 månader
Publiceringsdatum2021-02-13ErsättningFast lön
Så ansöker duSista dag att ansöka är 2021-02-21
Klicka på denna länk för att göra din ansökanFöretagPoolia Sverige AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "58760".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Poolia Sverige AB (org.nr 556426-7655),
http://www.poolia.se Körkort För detta jobb krävs körkort.
Arbetsplats Poolia Life Science & Engineering AB
Jobbnummer 5574786
Observera att sista ansökningsdag har passerat.