Regulatory Affairs Expert
HemoCue AB / Administratörsjobb / Ängelholm
2020-01-10
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➡️ Klicka här för den senare publicerade platsannonsen "Regulatory Affairs Expert" (publicerad 2021-07-14) ⬅️
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Lund,
Stockholm eller i
hela Sverige Temporary 12 months
Do you want to make a difference by developing key lifesaving medical device products? In a truly global business who refuse to compromise when it comes to caring for people.
It is vitally important for the company to stay on top of the changing regulatory environment around the world and understand the impact it might have on the HemoCue business and portfolio. We are now looking for a candidate that will strengthen our Regulatory Affairs team during 12 months.
Your responsibilities
Managing and coordinate medical devices reporting & field actions activities within related vigilance processes.
Ensure procedures and activities are in compliance with requirements
Support organization in regulatory questions regarding vigilance
Coordinate regulatory Q&A sessions with regulatory authorities in regards to vigilance
Participate in complaint investigations and field action activities with regulatory expertise
Qualifications
Proven good knowledge of regulations for IVD products (EU IVDD/IVDR, US FDA regulations 21 CFR), standards/regulations for quality management systems (ISO 13485, QSR) and risk management for medical devices (ISO 14971)
Minimum of 5 years of experience of similar products and/or other medical devices
Profound experience as MS Office user
Fluent in English and Swedish verbally and in writing
Personality
As a person you are a team player, systematic, structured and who likes a fast pace. You find it easy to communicate with other people and enjoy working in a company that is driven by continuous improvement, both in terms of equipment and processes.
Interviews will be held as soon as relevant candidates have been identified
We are not able to receive your application by other means than through the link
https://jobs.danaher.com/global/en/job/R1104660/Regulatory-Affairs-Expert. Please bring diplomas for face-to-face interviews. Any application by mail or e-mail will be returned.
We offer you
A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Sweden and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for training and career development.
We are looking forward to receiving your application no later than January 20.
For further information, please contact Director Regulatory Affairs, Rikard Almåker at tel. +46 734 14 03 89.
Union contacts: Mikael Godolakis, Unionen, +46 431 48 14 66 or Elin Söderlind, Akademikerföreningen, +46 431 48 12 62.
Publiceringsdatum2020-01-10Så ansöker duSista dag att ansöka är 2020-01-20
AdressHemocue AB
KUVETTGATAN 1
26223 ÄNGELHOLM
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Hemocue AB (org.nr 556342-9272)
Kuvettgatan 1 (
visa karta)
262 23 ÄNGELHOLM
Ansökan https://jobs.danaher.com/global/en/job/R1104660/Regulatory-Affairs-Expert
Arbetsplats HemoCue AB
Jobbnummer 5034202
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