Post Market Surveillance Manager

Fisher Paykel Healthcare; Howick; On-site; NZD 170,000 - 210,000; Full time

Benefits offered by this job

Employee share purchase scheme

Profit sharing

Life insurance

Health insurance

Annual salary review

Career development programs

Job summary

Fisher & Paykel Healthcare in New Zealand is seeking a Manager of Post Market Surveillance to lead all aspects of post market activities for Airvo and myAirvo products. You will report to the Head of Global Post Market Surveillance, building and developing a high-performing team and coordinating regulatory interactions across the globe.

You will drive quality improvements, manage regulatory communications, and influence strategic plans to maintain a competitive edge in post market surveillance.

Qualifications

• Proven leadership experience in medical device/pharmaceutical industries.
• Minimum 3 years in Quality and/or Regulatory Affairs with deep understanding of regulatory requirements (US FDA).
• Ability to communicate with senior management and key stakeholders globally.
• Ability to engage and develop a high performing team.
• Experience liaising with regulatory authorities including inspections and audits.
• Bachelor degree or equivalent in engineering, science, business, or similar.

Responsibilities

• Lead all aspects of Post Market Surveillance, supporting product teams in identifying, assessing and acting upon risks in the field.
• Minimise regulatory risk through analysis and communication of PMS data with regulators and internal teams.
• Contribute to development and deployment of global Quality & Regulatory strategic plans.
• Develop and deploy strategic plans for competitive advantage in post market surveillance.
• Lead and develop a high performing team of quality & regulatory professionals to meet business objectives.
• Continuously improve PMS practices and tools to world-class standards.

Skills

Leadership

Regulatory affairs

Stakeholder communication

Team development

Education

Bachelor degree or equivalent in engineering/science/business

Job description

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This role is a Manager of our Post Market Surveillance team supporting the Airvo and myAirvo (Nasal High Flow) Product Teams based out of New Zealand for FPH globally. Reporting to the Head of Global Post Market Surveillance, this role is critical to supporting our global business by leading all aspects of post market surveillance.

This role has responsibility for:

• Leading all aspects of Post Market Surveillance, specifically supporting the product teams in identifying, assessing and acting upon potential risks in the field
• Minimising regulatory risk through the analysis and communication of Post Market Surveillance data internally and externally with regulatory authorities
• Contributing to the development and deployment of global Quality & Regulatory strategic plans.
• Developing and deploying strategic plans that provide a competitive advantage in post market surveillance.
• Leading and developing a high performing team of quality & regulatory professionals that achieves strategic business objectives
• Continuously improving post market surveillance practices and tools to be world class.

About you

• Proven leadership experience in medical device and/or pharmaceutical industries.
• At least 3 years in Quality and/or Regulatory Affairs with a deep understanding of regulatory requirements (with specific expertise in US FDA requirements).
• Ability to effectively communicate with senior management and key stakeholders across a global business.
• Ability to engage & develop a high performing team
• Experience in communicating and interacting with regulatory authorities including during external regulatory inspections and audits.
• At a minimum, a university degree (Bachelor degree or equivalent) in engineering, science, business, or similar.

Quality is at the heart of our success as we constantly strive to ensure the very best for our customers, your valued contribution is vital to this. This could be the role for you.

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, while enjoying some of our perks and benefits:

• Employee share purchase scheme
• Discretionary bi-annual Profit share
• 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
• Banking and Insurance discounts
• Free Parking
• Beautiful campus with green spaces
• Annual Salary Review
• High rates of internal promotion
• Access to state-of-the-art facilities

About Us

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.

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 organizations such as Te Uru Tangata – Centre for Workplace Inclusion, 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 [e-mail] .