Senior Regulatory Affairs Specialist

About the Company

With over 5000 employees selling to over 120 countries, Fisher & Paykel Healthcare is one of the most well established and innovative companies in New Zealand.  Fisher & Paykel Healthcare are world leaders in the design and manufacture of medical devices for the treatment of Sleep Apnoea, Respiratory & Acute Care and Surgical Humidification. To enable our success to continue, we depend on the abilities of our Regulatory Affairs team members to ensure we are able to meet the registration requirements in our overseas markets.


About the role

As a Senior Regulatory Affairs Specialist at Fisher & Paykel Healthcare you will obtain and maintain market access for our cutting edge products by working with our New Zealand based team and relevant overseas regulatory authorities.  

  • You will be tertiary qualified, preferably in regulatory, engineering, science or law.
  • You will have a strong eye for detail, complemented by your methodical, analytical approach.
  • You will have proven strategic drive to improve regulatory submissions routes for efficient commercialization of medical devices.
  • You will be able to evaluate, summarize and clearly communicate market requirements to the New Zealand based team.
  • You will have 4+ years' experience working in a regulated industry, such as, medical devices, pharmaceuticals, food or aviation.
  • You will be fluent in English.
  • You will preferably have experience working with regulatory authorities.
  • It would be beneficial if you have also had experience in customer relations, managing and organising people, and in other ways demonstrating leadership skills.


Attitude is all-important with this role, and you will be driven to get stuck in to help achieve team plans. Working with systems and processes and utilising your planning and presentation skills will enable you to successfully lead projects, set strategy and build strong relationships within the company and with external stakeholders.


About the Culture

Our company recognises that innovation is a key ingredient to sustained growth and profitability. You will reap the rewards of working for an organisation that is focused on growing internationally and acknowledges their people through a comprehensive range of benefits, career opportunities and a great working environment.


If you are looking to excel in a successful, fast growing, and international industry - click the link to apply today!