41d ago

Regulatory Affairs Associate - Medical Device/IVD's

Hays


Base pay $80k - $90k
Permanent Standard business hours
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Full job description

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


Skills
FDA
LIFE SCIENCE
MEDICAL DEVICE
MEDICAL DEVICES
QUALITY ASSURANCE
REGULATORY DOCUMENTS
Pay comparison
Market average based on all Regulatory Affairs Associate jobs in Sydney NSW
Base pay range
$80k - $90k
Market average
$99k
$99k
Market average
$73k
$121k

Job details
Date posted
30 Jun 2022
Category
Science, Technology & Environment
Occupation
Medical Devices & Technology
Base pay
$80k - $90k
Work type
Permanent
Job mode
Standard business hours
Work Authorisation
Australian citizen / Permanent resident

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