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.

• 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

• 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

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