Job Opportunities API

Wir bei Baxter glauben, dass jeder Mensch – unabhängig von Herkunft oder Identität – ein Recht auf ein gesundes Leben hat. Dieser Grundsatz prägt unser Handeln seit unserer Gründung im Jahr 1931 – und er leitet uns auch heute. Unsere Mitarbeitenden sind durch eine gemeinsame Mission verbunden: Leben zu retten und zu erhalten. Dabei fördern wir eine Kultur, die von Vertrauen, Eigenverantwortung und Teamgeist getragen wird. Jeder bei uns ist ermutigt, Verantwortung zu übernehmen, mitzugestalten und die eigene Wirkung zu entfalten. Wir arbeiten gemeinsam an schlanken, wirkungsvollen Prozessen und übernehmen Verantwortung für exzellente Ergebnisse. Hier finden Sie mehr als einen Job - Sie finden Sinn und Erfüllung. The Role We have an exciting opportunity for a QARA Specialist to join our QARA team at Baxter for a 6-month fixed-term role. Reporting to the Head of QARA – ANZ, you will work collaboratively with the Operations, Quality , Regulatory and Supply Chain teams, enabling the timely delivery of fully compliant products and processes in line with the ANZ Commercial Business Plan. With a key focus on regulatory and quality, your role will support the effective management of 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. If you are a passionate regulatory and quality professional looking to make a meaningful impact on patients’ 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 Quality Assurance • 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. Regulatory Affairs (Medical Devices) • 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. Key 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. li-baxgen LI-JB1 ind-aus Equal Employment 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. 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 .