Senior Regulatory Affairs Expert
Dfind Science & Engineering AB / Apotekarjobb / Ängelholm
2017-07-21
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Are you an expert in regulatory affairs within medical device? Do you have the experience to work with the US market and are an excellent communicator? Do you want to work for a truly global business who refuse to compromise when it comes to caring for people? If your answer is yes, you may be the candidate we are looking for!
HemoCue develops, produces and markets easy to use diagnostic systems for the Professional Point of Care markets. We are global market leaders in Hemoglobin testing and hold strong positions in other served product segments. 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 the right candidate that in the future will play an important role for the regulatory strategies to come for HemoCue.
You will be responsible for i.e.
• Monitoring, interpretation and communication of regulatory requirements
• Ensure procedures and activities are in compliance with requirements
• Support organization in regulatory questions
• Review and approval of labelling and marketing material
• Compilation and maintenance of regulatory submissions
• Lead and coordinate regulatory Q&A sessions with regulatory authorities
• Participate in product development projects with regulatory expertise
You will report to the Director Regulatory Affairs and be placed in Ängelholm, Sweden.
We are offering a dynamic, innovative and challenging position where you will be able to work with regulatory affairs in an independent and global role.
Qualification:
We are looking for a person with the following experience and qualification:
• Master degree in Engineering, Pharmacy, Biology, Chemistry, or similar.
• 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
• It is a great advantage to have knowledge of regulatory submissions for IVD products in the US
• Project leader skills
• Profound experience as MS Office user
• You have excellent English in speech and writing, Swedish is an advantage
On a personal level, you have excellent communications skills . You have the ability to work in a high matrix environment. You are self-motivated and you have the ability to plan and execute activities with minimal supervision. You strive to deliver results. We place great emphasis on personal qualities for this role.
Company: HemoCue AB
City: Ängelholm
Job type: Full time
Deadline for applications: 2017.08.20
More information: This recruitment will be managed by Dfind Science & Engineering. For more information about this position please contact Recruitment Consultant Camilla Wern 0733-436098 or Malin Jessen 072-9889504. Please send in your application in English via
https://www.dfind.se/science-engineering/Organization/Business description:
Because When it Comes to Caring for People, We Refuse to Compromise
HemoCue, part of the Radiometer Group since April 2013, is a global leader in point-of-care testing. HemoCue AB (Ängelholm, Sweden), introduced in 1982 the first accurate, near-patient hemoglobin test. The company also sells point-of-care tests for glucose, urine albumin, HbA1c, total and differential white blood cell count. For further information, visit
www.hemocue.com.HemoCue is operating in an important and growing global healthcare diagnostic segment - primary care. Currently an independent entity within Danaher, directly overseen by Radiometer Group, HemoCue is guaranteed an interesting and dynamic future, as DHR-Dx maximizes the value of its investment in HemoCue, by thinking HemoCue into the strategy to enter more POL market segments.
HemoCue is an environment where talent can own truly global, end-to-end value chain responsibility within any function, with all the complexity that this carries. HemoCue is a top-of-the-line career platform, both for HemoCue internal advancement, for advancement within DHR, and for advancement in other companies on the back of the DHR brand.
Key words: IVD products, RA, regulations, Quality, ISP 13485, QSR, medical devices, regulatory affairs, risk management, US, FDA
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-07-21ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-08-20
Ange följande referens när du ansöker: 201067443
Klicka på denna länk för att göra din ansökanKontaktCamilla Wern
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Styrmansgatan 2
26271 Malmö
KontorsadressStyrmansgatan 2, 21118 Malmö
Jobbnummer 3612994
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