Regulatory Specialist

2 days 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.



  • Auckland City, New Zealand Airways Full time

    **About Airways**: Our people manage New Zealand's 30 million square kms of airspace, providing air traffic control, surveillance, communication, flight inspection, mapping, and airspace design services. We work with government, regulatory authorities, airlines, airports, and the general aviation community to ensure pilots, passengers and goods reach their...

  • Regulatory Specialist

    2 weeks ago


    Auckland City, New Zealand New Zealand Government Full time

    Discover a career with purpose at MBIE - **Discover a career with purpose at MBIE**- Grow your regulatory compliance and investigation experience - Use your ability to influence and build relationships within the building and construction industry - Central Auckland or Manukau based, permanent full-time role - Salary range: $85,537 to $101,911 + KiwiSaver +...


  • Auckland City, New Zealand ICON Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...


  • Wellington City, New Zealand New Zealand Government Full time

    Work with a Portfolio of Stakeholders, - Travel NZ on site visits and train staff, - Wellington home base with ambitious team Kōrero mō te tūranga - About the role We have two newly created Senior Customer Regulatory Specialist roles in our Crown Property Group following a change implementation designed to bring us closer to our customers. This sees us...


  • Auckland City, New Zealand ICON Full time

    **Location**:Australia or New Zealand** - ‘At ICON, it's our people that set us apart’_ As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you...


  • Auckland City, New Zealand Auckland Council Full time

    Permanent Full-time role based at Central Auckland - Varied and challenging role in a supportive team environment - Long term career development and progression opportunities on offer **He angitūtanga: The opportunity** Auckland Council’s Regulatory Services division is looking for a motivated permanent full time Regulatory Support Officer. You will...


  • Auckland City, New Zealand Rabobank Full time

    Rabobank is the world’s leading specialist in food and agribusiness banking. One of our key strengths lies in our people who have a deep understanding of agriculture and are committed to adding long-term value for clients. Our purpose is clear: we enable our clients to feed the world sustainably. Our commitment to our employees and customers is at the...


  • Wellington City, New Zealand Land Information New Zealand Full time

    **Join Toitu Te Whenua LINZ!** We ensure the certainty of private property ownership by recording and sharing survey and land title information, supporting economic activity. **If you thrive in a process-based, analytical environment and enjoy being part of an agile team, we want you!** - **Make a real impact**:Help maintain New Zealand's land information...


  • Auckland CBD, New Zealand Tyler Wren Full time

    About the Role: Step into a pivotal position as Regulatory Assurance Manager with a leading international banking institution based in Auckland CBD. In this role, you'll shape regulatory compliance, strengthen risk frameworks, and deliver assurance activities that support high-quality governance across the bank. This opportunity is ideal for a skilled...


  • Wellington City, New Zealand New Zealand Government Full time

    **Kōrero mō te tūranga - About the role** We are excited to announce we have two newly created Senior Customer Regulatory Specialist role within our Crown Property team. These roles are part of a recent change initiative aimed at fostering closer relationships with our customers and developing a more strategic approach to managing the Crown property...