
RAQA Specialist
Overview
This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
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Support for Parents
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Continuing Education/ Professional Development
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Employee Heath & Well-Being Benefits
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Paid Time Off
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2 Days a Year to Volunteer
Success Profile
What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.
- Detail Oriented
- Continuous Learner
- Courageous
- Collaborative
- Critical Thinker
- Influential
RAQA Specialist
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
The Role
We have an exciting opportunity for a RAQA Specialist to join our RAQA team at Baxter for a 6 month fixed term role. Reporting to the Regulatory Affairs and Quality Manager you will work collaboratively with the Operations, Quality and Supply Chain teams, enabling timely delivery of fully compliant products and processes as per the ANZ Commercial Business Plan.
With a key focus on Regulatory, your role will include working on effective management of the Quality Management Systems, management reviews, management of product complaints, nonconforming products, CAPA, internal audits, quality records control, training and supplier controls, in order to maintain certification to ISO9001. If you are a passionate regulatory professional looking to make a significant impact on patient lives, we’d love to hear from you!
This is where you can do your best work. Where your purpose accelerates our mission.
Key Responsibilities:
Manage regulatory activities to portfolio of products / projects with minimal supervision
Maintain and update existing regulatory authorisations including but not limited to preparing regulatory submissions for TGA and MedSafe listing, annual registration reviews, manufacturer evidence maintenance, regulatory database maintenance and commercial releases
Respond to regulatory authorities’ questions with strict deadlines
Develop and initiate regulatory project plans and strategies
Provide regulatory impact assessments for changes to existing products and processes, new regulations and updates to standards including project planning, developing regulatory strategies, communicate country-specific requirements, forecast approval timeliness and minimise risk and time to product launch
Drive the complaint and feedback handling systems. Co-ordinate the investigation of patient incidents and as required the filing of device incident reports to regulatory bodies
Review and approve labelling/promotional/advertising materials (AdProm), change order assessment and approval, and other documents to ensure compliance to the appropriate regulations
Assist QARA Manager in the day-to-day operations of the Quality Management System including but not limited to: management reviews, management of product complaints, nonconforming products, CAPA, internal and external audits (ISO and MDSAP), quality records control, training and supplier controls, in order to maintain certification to ISO9001
Ensure the maintenance of licences and permits where applicable
Act as a contact person for all inquiries pertaining to registrations and tender requests.
Key Requirements:
Tertiary degree in Science or related fields
5 years or more experience working in Regulatory environment within the Medical devices industry is desirable
Good understanding and working knowledge of Australian and New- Zealand medical device regulations and EU regulations
Project management experience is highly regarded
Highly developed interpersonal effectiveness and relationship-building abilities
Collaborative approach and ability to work well with others.
Why Baxter?
At Baxter ANZ, we are focused on being a Best Place to Work where our people can be their authentic self, feel valued and respected. We are committed to a culture where all employees can collaborate and work together effectively. Relationships are a key component in how we operate in Baxter and we share the common traits of being reliable, ethical, caring, having empathy, actively listening to our colleagues as well as being open minded to new ideas and perspectives. Baxter is an organisation that makes inclusion and diversity a priority and that seeks to promote and improve gender equality in the workplace.
Baxter is proud to be recognized as an Inclusive Employer by the Diversity Council of Australia. We are also committed to delivering support structures for working families; stronger actions to address pay inequalities; and strategic recruitment and promotion practices that help to encourage the full participation of all people at work.
Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or any other status protected by law. Baxter encourages applicants of all ages.
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Reasonable Accommodations
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.
Recruitment Fraud Notice
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.
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