Senior Regulatory Affairs Associate

Location
Australia
Salary
Competitive salary with excellent benefits and bonus strucutre
Posted
04 May 2021
Closes
03 Jun 2021
Hours
Full Time
Contract Type
Permanent
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.

Requirements:

  • 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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