Regulatory Affairs Specialist

at  Fisher Paykel Healthcare

• Join a leading NZ-owned business improving patient outcomes globally
• Vast career development opportunities and employee benefits on offer
• Be part of a team that is focused on global commercialization of our products
  Do you currently work in a regulated industry? Are you looking to add value and grow within a reputable company that makes a difference in the lives of millions of customers?

ABOUT US

Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally. We are an iconic New Zealand company with a consistent growth strategy ensuring an expanding range of innovative devices for use in respiratory care, acute care and the treatment of obstructive sleep apnea.
We focus on nurturing a positive and inclusive culture based on trust and respect. In New Zealand, our employee-led communities, Spectra (rainbow), Manaaki (Māori) and Women in Engineering play an important role in this culture. We also have a commitment to creating a positive lasting impact on society, shown by our support of New Zealand organisations such as Diversity Works NZ, Pride Pledge and Global Women.

At Fisher & Paykel Healthcare we improve patient care and outcomes through inspired, world-leading healthcare solutions.
As designers, manufacturers and marketers of innovative medical devices, we are required to comply with a wide range of country specific regulations and require market clearance prior to commercialisation for new and modified products.
As a Regulatory Affairs Specialist, you will support the global commercialisation of leading and innovative medical device products while also driving efficiencies in our regulatory processes.
Partnering with teams across the business, you’ll identify opportunities to create and improve process change, enabling quicker market access for new and modified products.
This role focuses on regulatory activities to support the business and wider regulatory team to gain market access instead of directly working regulatory submissions.