Senior Regulatory Affairs Associate

Competitive salary with excellent benefits and bonus strucutre
04 May 2021
03 Jun 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

The company is a top tier global Medical Device company with an established portfolio of devices spanning across multiple therapeutic areas.

Job Scope:

  • Support the local Regulatory Affairs (RA) team and liaise closely with international colleagues to prepare and complete regulatory submissions across various regions.
  • Provide mentorship to more junior team members and guide them along for regulatory submissions.
  • As a representative of the RA team, to liaise with team members on cross functional teams (QA, Engineering, Supply Chain) to ensure successful delivery of projects.
  • Prepare and maintaining technical documentation (design and technical dossiers) for device regulatory submissions globally for the company.
  • Support the RA managers in the development and execution of the RA Strategy for the company.


  • Degree in a relevant discipline (Life Sciences, Engineering, Pharmacy)
  • At least 4 years of Regulatory Affairs experience in the Medical Device industry in Australia and New Zealand (experience with Class I, IIa, IIb, III devices)
  • Familiarity with EU MDR will be advantageous for the role
  • Experience in a medical device manufacturing/engineering design setting will be useful for this role
  • Organized individual with a strong eye for detail
  • Innovative and collaborative individual

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