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Regulatory Specialist

1 month ago


Auckland City, New Zealand Aroa Biosurgery Full time

Regulatory Specialist
- Be part of a growing kiwi success story within a supportive and fun-loving team
- On-site Gym and plenty of Free Parking
- Work in a Diverse and Inclusive Team

**About Aroa
Here at Aroa Biosurgery we're unlocking regenerative healing for every _body. _Maori for ‘understanding’, AROA is making and creating innovative and regenerative healing products that are improving the lives of millions of people around the world. We specialise in developing, manufacturing and exporting new and exciting soft tissue regeneration products utilising our successful Endoform extracellular Matrix (ECM) biomaterial.

We have been on quite a journey here at AROA over the last 12 years and we continue to go form strength to strength each time we hire someone new to our company. We have truly ambitious goals here at AROA and we know that it's our people and the culture of the business that sets us apart from the rest. As a medium sized business, we operate in that lovely space where every person can make a huge impact on the results and future of the business.

We listed on the ASX in July 2020, (in fact, the first company to list on ASX post the COVID-19 breakout) and with an additional capital rise since then (due to investor demand), we’re primed for exponential growth in the coming years

What you’ll be doing

We’re looking for a full time Regulatory Specialist to provide quality assistance in the administration an coordination tasks required to obtain and maintain global market authorisation of Aroa products and ensure continued regulatory compliance.
- Key responsibilities: _
- Prepare registrations as per current global registration plan
- Prepare submission content in line with local regulatory requirements and guidelines
- Represent Regulatory Affairs on Product Development projects
- Prepare and execute tasks associated with the US FDA 510(k) premarket notification requirements
- Monitor proposed and current global regulations and guidance, and assess impact of such regulations and guidance on assigned products/projects

What you’ll bring
- A Bachelor's degree, or similar
- 2+ years’ experience working within the medical device industry or similar
- Experience with medical device regulatory requirements
- Quick learner with a positive attitude
- Able to work within a team environment

You will be an adaptable self-starter with excellent written and oral communication.

Based in Airport Oaks with easy access to the motorway, there is plenty of parking available around our offices. Our teams are flexible, with a mix of being in office + working from home. We also have an on-site gym, which is available for individual use, or jump in to one of our bootcamp or yoga classes.


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