Regulatory Affairs Associate - Medical Device/IVD's

This is an Exciting opportunity to work with Molecular diagnostics with a growing organisation.

Your new company
This organisation is a small but rapidly growing biotech company working on the detection of infectious diseases. This company is headquartered in Sydney and is looking for a Regulatory professional to join their growing team.

Your new role
This role is to support the team with Regulatory submissions of products to regulatory bodies such as TGA and Medsafe to create, new an innovative molecular diagnostics to improve patient outcomes. You will be responsible to develop and maintain Regulatory documents to meet the standards required locally and globally. Liaise with Regulatory manager to implement regulatory strategy and Assist in preparing documents and submissions for company and IVD registration. You will also be responsible for internal external audits and working closely with other areas such as R&D, production, marketing and Validation.

What you'll need to succeed

  • Experience with IVD's or Medical Devices
  • Sound understanding of ISO13485, TGA FDA and other regulatory bodies
  • Tertiary qualification in life science related field
  • Experience working in Regulatory Affairs /Quality Assurance
  • Excellent communication skills
What you'll get in return
This company is an exciting opportunity to work with a growing organisation in an niche and exciting space. The company offers flexible working and excellent salary package.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

LHS 297508 #2673873


Job Type
NSW, Sydney CBD
Life Sciences

Talk to a consultant

Talk to Shannon Hackney, the specialist consultant managing this position, located in Sydney
Level 13, Chifley Tower, 2 Chifley Square

Telephone: 0280626177

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