Post Market Surveillance Associate

Fisher & Paykel Healthcare; Auckland; On-site; NZD 90,000 - 130,000; Full time

Job summary

Fisher & Paykel Healthcare in Auckland is seeking a Post-Market Surveillance specialist to analyse product feedback, identify risks, and drive continuous improvement in quality and regulatory outcomes. You will contribute to global compliance and patient safety.

The role requires collaboration with marketing, sales, development, and manufacturing to manage vigilance reports to regulatory bodies and to coordinate cross-functional actions across 120+ countries.

Qualifications

• Tertiary qualification in health sciences, engineering, law or business.
• Experience in a Post Market Surveillance, Quality or Regulatory Affairs role, Pharmaceutical or Medical Device industries preferred.
• Strong attention to detail and analytical capabilities.

Responsibilities

• Analyse product surveillance feedback to identify risks and opportunities for improvement.
• Submit vigilance reports to international regulatory bodies to maintain compliance and reduce regulatory risk.
• Collaborate with marketing, sales, product development, manufacturing and clinical teams to drive quality outcomes.

Skills

Post-market surveillance

Regulatory affairs

Attention to detail

Interpersonal skills

Analytical mindset

Influencing skills

Education

Health sciences / Engineering / Law / Business degree

Job description

Fisher & Paykel Healthcare – Auckland, North Island

Our story began more than 50 years ago, when one doctor and two engineers designed a better way to care. Today, we are a thriving global business, and our products, used in acute and chronic respiratory care, surgery and the treatment of obstructive sleep apnea, make a difference to millions of patients every year.

Care to find solutions

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

About the opportunity

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 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 be responsible for analysing product surveillance feedback to identify risks and opportunities for continuous improvement. You will gain valuable insight into our products and their performance in the market, while contributing to ongoing product improvements that support quality, compliance, and customer outcomes.

In this is a permanent position, you will submit vigilance reports to numerous international regulatory bodies to maintain compliance and limit regulatory risk, including the Food and Drug Administration (FDA) in the USA. You will also build relationships with multiple areas of the business, including marketing, sales, product development, manufacturing, and clinical teams.

About you

• Tertiary qualification in health sciences, engineering, law or business.
• Experience in a Post Market Surveillance, Quality or Regulatory Affairs role, Pharmaceutical or Medical Device industries preferred.
• Strong attention to detail
• Effective interpersonal skills
• Strong analytical skillsInquisitive nature
• Demonstrated influencing skills

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.

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 (Máori) 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.

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 *******@fphcare.co.nz.