Fisher & Paykel Healthcare is seeking a Post Market Surveillance Manager to lead our team supporting the Airvo and myAirvo product lines globally. Reporting to the Head of Global Post Market Surveillance, this role is critical for managing field risks and ensuring regulatory compliance across our international business.
What You'll Do
- Lead all aspects of Post Market Surveillance, supporting product teams in identifying, assessing, and acting upon potential field risks.
- Minimize regulatory risk by analyzing and communicating Post Market Surveillance data internally and with regulatory authorities.
- Contribute to the development and deployment of global Quality & Regulatory strategic plans.
- Develop and deploy strategic plans that provide a competitive advantage in post market surveillance.
- Lead and develop a high-performing team of quality and regulatory professionals to achieve strategic business objectives.
- Continuously improve post market surveillance practices and tools.
What We're Looking For
- Proven leadership experience in the medical device and/or pharmaceutical industries.
- At least 3 years in Quality and/or Regulatory Affairs with a deep understanding of regulatory requirements, including specific expertise in US FDA requirements.
- Ability to effectively communicate with senior management and key stakeholders across a global business.
- Ability to engage and develop a high-performing team.
- Experience communicating and interacting with regulatory authorities, including during external inspections and audits.
- A university degree (Bachelor degree or equivalent) in engineering, science, business, or a similar field.
Team & Environment
You will be the Manager of the Post Market Surveillance team, reporting directly to the Head of Global Post Market Surveillance.
Benefits & Compensation
- Employee share purchase scheme
- Discretionary 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
- Subsidised Café’s
- Annual Salary Review
- High rates of internal promotion
- Access to state-of-the-art facilities
Work Mode
This is an on-site position based in New Zealand.
We are dedicated to designing our recruitment process with care and empathy to support all candidates, regardless of identity, background, and experiences.
