Regulatory Affairs Invitro Diagnostics

Date posted: Fri 12 November 2021

  • Passionate team
  • Europe, Australia and NZ markets
  • In demand testing methods

The Role
As the Regulatory Affairs Manager your role is a key position in securing regulatory approval for key products in the invitro diagnostics and medical devices sector within Europe and Australasia as well as having some involvement with the US market.  You will be working in Auckland Central location and interact with the local manufacturing facilities.
 
The company
This dynamic and innovative organisation has developed rapid screening techniques using a patented technology for a number of important infective diseases. They have local manufacturing and distribution and their research and development have a pipeline of products.
 
Requirements
The importance of this position will require you to have:

  • Bachelor or master's degree in the life science or engineering area
  • Experience in regulated environments/regulatory agency interactions required
  • Knowledge and experience of global medical devices and product regulations (e.g. EU Medical Device Regulations, ISO, FDA,... ) are strong assets
  • Experience in CE submissions for IVD products is essential. Experience in FDA 510K submissions for IVD products would be an asset.
  • Experience leading and facilitating audits
     
Contact
For a confidential discussion please email a resume to gary@synergyconsult.co.nz or phone Gary Beattie on 09 360 4801.
REF: 4732
 

Synergy Consulting Group is the trusted recruitment and career advisor in the medical and pharmaceutical sectors in New Zealand. We are actively recruiting Sales Representatives, Product Specialists, Sales Management, Clinical Support and customer services roles.

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Overview

Type: Permanent
Area of Interest: Clinical
Location: Auckland
Reference: 4732

  • Passionate team
  • Europe, Australia and NZ markets
  • In demand testing methods

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