Job Description

Care to Make a Difference?

Join a team of good people doing good work with intent. People like you, who care to make a difference.

About the Role

As designers, manufacturers, and marketers of innovated medical devices, Fisher & Paykel Healthcare needs to meet a wide range of standards, regulations, and guidelines to achieve timely market access in over 120 countries.

This is a permanent full-time opportunity, primarily support the regions of China, Taiwan, Hong Kong and Macau. As a Regulatory Affairs Specialist you will:

• Ensure the business is aware of constantly changing regulations and requirements.
• Collaborate with cross-functional teams such as Design, Quality, and Marketing to develop an effective market access strategy.
• Interact with regulatory bodies, managing relationships with regulators, and being able to communicate and present technical elements in a way that the regulator can understand.
• Deliver timely regulatory submissions.
• Resolve regulatory issues and identifying opportunities for improvement.

About You

Attitude is all-important with this role, and you will be driven to get stuck in to help lead projects, set strategy, and build strong relationships within the company and with external stakeholders.

• You will be tertiary qualified, preferably in Law, BioScience, Engineering, or Science with the ability to write technical documentation.
• You will have 2+ years' project management experience working in a regulated industry.
• Fluency in English and Mandarin (reading, writing, and speech) – be able to evaluate, summarize, and clearly communicate market requirements and write dossiers.
• You will have a strong eye for detail, complemented by your methodical, analytical approach.
• You have a continuous improvement focus and a solutions-oriented attitude, enabling you to think outside the box and work with rigour to lead improvements to our regulatory processes.

Working With Us

Care to join a supportive environment?Fisher & Paykel Healthcare foster an inclusive work environment founded on our culture of care and cooperation. Here you’ll have the trust and support to generate ideas, solve problems and do your best work,

About Us

Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally. Our commitment to care unites us. Here, we’re driven to improve patient care and outcomes through inspired and world-leading healthcare solutions.

Care to join us? Apply today

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 organizations such as Te Uru Tangata – Centre for Workplace Inclusion, Pride Pledge and Global Women.

We are dedicated to designing our recruitment process with care and empathy to support all candidates, regardless of identity, background, and experiences. Should you require support or adjustments during our process, please let us know at recruit@fphcare.co.nz

Requisition ID: 6175
Posting end date: ​ 02/03/2026