Post Market Surveillance Specialist

6 months ago


East Tamaki, New Zealand Fisher & Paykel Healthcare Full time

**About the role**

Our Quality & Regulatory team is dedicated to improving patient care and outcomes. The global Post-Market Surveillance team drives this continuous improvement by monitoring our products and services in the market, raising awareness of any quality issues, and influencing executive management to take corrective and preventative action. We also manage post market regulatory compliance in the 120+ countries we sell our products in.

We currently have an opportunity for a motivated individual to join our team. In this position you will regularly liaise with international regulatory bodies, such as the Food and Drug Administration (FDA) in the USA. You will be responsible for analysing product feedback and, where necessary, preparing and providing reports to international regulatory bodies to maintain compliance and limit regulatory risk. You will also support any field actions to ensure our products continue to be safe and effective. You will build relationships with all areas of the business, including executive management, marketing, sales, product development, manufacturing, and clinical. You will also regularly liaise with Fisher & Paykel Healthcare regional offices to support their post market surveillance activities.

**We are looking for someone with;**
- Experience in Quality and/or Regulatory roles will be an advantage
- Tertiary qualification in health sciences, nursing, engineering, law or business
- 1-3 years’ experience working in a regulated industry
- Strong attention to detail
- Excellent formal writing and verbal communication
- Effective interpersonal skills
- Strong analytical skills and critical thinking
- Inquisitive nature
- Demonstrated influencing skills
- Risk assessment experience

**Our Company 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 and Medela products
- School holiday programme subsidy
- Banking and Insurance discounts
- Free Parking
- Beautiful campus with green spaces
- 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.

If you have a passion to grow and develop, we want to hear from you



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