AddressAbout Us:
Rapid Response Revival (RRR) is an Australian owned, Medical Device innovator. Based in Riverwood, we design, manufacture and supply automatic external defibrillators (AED’s) for multiple global markets with our priority centered around developing AED solutions that make portable defibrillation affordable, accessible and effective. We are looking for a full-time permanent, Senior Regulatory Affairs professional to join our office based team with flexibility for occasional hybrid work options.
The Opportunity
The Senior Regulatory Affairs Associate supports all Regulatory Affairs activities by monitoring our products and services in market, raising awareness of any quality issues, and influencing decisions to take corrective and preventative action.
Acting as a key point of contact, you will liaise with international regulatory bodies and build cooperative working relationships with cross functional teams, partnering to assist with obtaining regulatory approvals in support of RRR’s new market expansion opportunities, whilst managing complaint handling, investigations, reporting and field actions as applicable.
Central to your success will be your ability to develop a strong working knowledge of the product, usage, limitations, market, and technical documentation. The Senior Regulatory Affairs Associate will demonstrate the RRR Values of People First, Lead with Care, Never Settle, Think Smart.
About you
Bachelor’s level qualification in science, engineering or a related discipline
Significant experience working in a Regulatory Affairs role within a medical device organisation in Australia or overseas.
obtaining regulatory approval.
Demonstratable experience liaising with FDA, Notified Bodies and TGA on complaints handling
Demonstrated knowledge in EU MDR/US FDA/AU TGA/ NZ Medsafe regulations and guidelines
Experience using an electronic quality management system or document management system
Experience organising, analysing and presenting data
Sound skillset in Microsoft Office, Greenlight Guru, Adobe PDF Pro, JIRA, Confluence
Team player with a can-do attitude
Why should you apply?
Contribute to a forward-thinking, collaborative, energetic and innovative team.
Opportunity to be part of an exciting start-up as we look to scale and take on new regions.
Personal interest in technology driven innovation and product development from design to manufacture.
Work for an Australian Manufacture, blazing a trail in the global Medical Device industry.
Apply today and make 2024 the year you become a lifesaver.
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