Regulatory Affairs Specialist

6 months ago

East Tamaki, New Zealand Fisher & Paykel Healthcare Full time

**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.

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.

**Skills & Experience**
- 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.

**Benefits**
- Access to state-of-the-art facilities
- Free Parking
- Beautiful campus with green spaces
- Subsidised onsite café’s
- Annual salary review
- Bi-annual profit share
- Generous paid parental leave
- Insurance offerings
- EV charging stations and showers & changing facilities to encourage lower-impact transport choices

**About Us**

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.

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