Regulatory Affairs Specialist

**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 the role**

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.

**About you**
- You will be tertiary qualified, preferably in engineering, science or law.
- You will have 4+ years' experience working in a regulated industry such as, medical devices, pharmaceuticals, food manufacturing or aviation.
- You will have a continuous improvement mindset and a solutions-focused attitude, enabling you to think outside the box to lead improvements to our regulatory processes and remove barriers to market access.
- You will have experience using data visualisation tools such as Power BI and Smartsheet.
- You will have a methodical, analytical and strategic approach to your work together with a strong eye for detail.
- You can build strong relationships with a variety of stakeholders to actively engage and influence.

**Benefits**
- Employee share purchase scheme
- Bi-annual Profit share
- Generous Paid Parental Leave
- Life, Critical illness and Income Protection Insurance
- Discounted Health Insurance
- Active Social clubs & community groups
- In-house training programs from external providers
- Purchasing privileges for Fisher & Paykel Healthcare products
- School holiday programme subsidy
- Banking and Insurance discounts
- Free Parking
- Beautiful campus with green spaces including EV charging stations and end of trip facilities to encourage lower-impact transport choices
- Subsidised Café’s
- Annual Salary Review
- High rates of internal promotion

**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.
- Requisition ID: _4239_
- Posting end date:_