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Regulatory Affairs Manager - Denmark  

NORDIC Bioscience (company)

Posted on : 12 April 2017

Project Description

  • Our company  has for more than two decades developed and manufactured novel in vitro diagnostic devices, i.e. enzyme-linked immunosorbent assays (ELISAs). 
  • We have obtained regulatory approval of these products in both Europe and the US and we continue to file applications for newly developed tests.  
  • Reorganizing our small regulatory group, we are seeking a Regulatory Affairs Manager to take responsibility for this important area within the company.
  • Reporting to our CEO , the RA Manager will be responsible for all aspects of regulatory submissions including interaction with our research department and Central Laboratory to complete the technical and clinical files, drafting of regulatory applications and subsequently interaction with the regulatory bodies eventually leading to clearance/approval of our new products. 
  • To meet our strategic goals, we anticipate to add additional regulatory officers over the next few years. 

Manager must
  • Hold a Master of Life Science 
  • Have significant experience with in vitro diagnostics devices 
  • Have hands-on experience with regulatory clearance/approval of in vitro diagnostic devices, primarily for the US market 
  • Fluent proficiency in English, both oral and written. 

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