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About the Role

This role supports the effective management of the Quality Management System, including management reviews, product complaints, nonconforming products, Field Actions, CAPA, internal audits, quality records control, training, and supplier controls, to maintain ISO 9001 certification. The position focuses on regulatory and quality aspects to enable the timely delivery of fully compliant products and processes in line with the ANZ Commercial Business Plan.

Responsibilities

Support the effective operation and continual improvement of the Quality Management System (QMS) in accordance with applicable procedures, standards and certification requirements.
Coordinate quality activities including nonconforming products, CAPA, quality records, training, supplier controls and management review inputs.
Support internal and external audits, including audit preparation, response coordination and follow up of corrective actions.
Drive complaint and feedback handling activities, ensuring investigations are completed, documented and escalated appropriately.
Support product quality investigations, risk assessments and quality decision-making activities.
Coordinate Field Actions and post-market activities, including reconciliation, effectiveness checks and closure activities.
Review quality impacts associated with product, process, supplier and manufacturing changes, ensuring appropriate controls and documentation are implemented.
Partner with Operations, Supply Chain, Commercial and other stakeholders to identify compliance risks and implement effective corrective actions.
Provide regulatory support for Baxter's medical device portfolio across Australia and New Zealand.
Maintain regulatory authorisations and registrations, including ARTG entries, manufacturer evidence, Medsafe WAND records and associated regulatory databases.
Prepare and coordinate regulatory submissions, notifications and responses to regulatory authority requests within required timeframes.
Assess regulatory impacts associated with product, manufacturing, supplier, labelling and design changes.
Support post-market regulatory activities, including vigilance reporting and regulatory notifications where required.
Review and approve medical device labelling, promotional and advertising materials, tender documentation and customer-facing communications to ensure regulatory compliance.
Monitor changes to applicable regulations, standards and guidance documents and communicate impacts to relevant stakeholders.
Act as a key point of contact for regulatory enquiries from internal and external stakeholders.

Requirements

Tertiary qualification in Science, Engineering, Quality, Regulatory Affairs or a related discipline.
Experience in Quality Assurance and/or Regulatory Affairs within the medical device, healthcare or other regulated industry.
Working knowledge of Quality Management Systems, including complaints, CAPA, audits, document control and supplier quality processes.
Understanding of Australian and New Zealand medical device regulatory requirements.
Knowledge of ISO 9001 and ISO 13485 requirements is highly regarded.
Strong organisational, communication, and stakeholder management skills.
Ability to manage multiple priorities and work effectively in a collaborative environment.

Skills

Quality Management System
Product Complaints
Nonconforming Products
Field Actions
CAPA
Internal Audits
Quality Records Control
Training
Supplier Controls
ISO 9001
ISO 13485
Regulatory Affairs
Medical Devices
ARTG entries
Medsafe WAND records
Vigilance reporting
Risk assessments
Stakeholder management

Location

Australia
New Zealand

Work Type

Fixed-term

Experience Level

Specialist

Education Level

Tertiary qualification in Science, Engineering, Quality, Regulatory Affairs or a related discipline

About the Company

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
This is where you can do your best work. Where your purpose accelerates our mission.

Equal Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.