Senior Regulatory Specialist

Vacancy number • PUB407451

Brunel is currently partnered with a world-leading, ASX-listed biosensors company that is a major supplier to several different industries. They are searching for a Senior Regulatory Affairs Specialist for their office in the heart of Melbourne, with expertise in developing and implementing a clear global regulatory strategy.

About this role

  • Lead regulatory approval projects for medical products in key markets like EU and US
  • Manage clinical and vigilance aspects of new and existing products
  • Prepare and maintain medical device files for submission to global regulatory authorities
  • Maintain regulatory license databases and systems
  • Communicate with regulatory agencies and conformity assessment bodies
  • Provide regulatory support to ongoing projects as needed
  • Assist in coordinating post-market surveillance activities with FDA, TGA & EU IVDR requirements

Requirements

  • BSc in a scientific field or related
  • Experience creating regulatory documentation for submissions
  • Strong experience with the following standards: ISO13485, ISO14971, 21 CFR 820
  • Ability to work flexibly across different timezones
  • Ability to work in a fast-paced environment and able to hit the ground running

Benefits

  • Opportunity to work in a fast-paced environment
  • Great team culture
  • Competitive package (up to $130,000 dependent on experience)

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Any questions remaining?

Your consultant, Louise Cleland is happy to clarify anything about this vacancy. When reaching out, use the pub number: PUB407451

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