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.

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.

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!

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.