Quality and Regulatory Specialist

5 months ago

Old Toongabbie, Australia BAXTER Full time

**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**:
Are you ready to take your career to the next level? Look no further We are seeking a Quality and Regulatory Specialist to join our exceptional ANZ QARA team in this 12 month fixed term role.

Reporting to the QARA Manager, you will play a crucial role in ensuring the flawless quality and regulatory compliance of our products. Your exceptional attention to detail and expertise will be essential as you collaborate with cross-functional teams to develop, implement, and maintain quality and regulatory strategies. You will be responsible for conducting audits, identifying areas for improvement, and ensuring that all processes are in strict adherence to regulatory requirements. Your proven ability to successfully implement quality and regulatory initiatives will contribute to our ongoing commitment to excellence.

**Key Responsibilities**:

- Act as the ‘Sponsor’ contact in Australia for TGA, ERAC and other applicable regulatory bodies
- Compile and submit, regulatory submissions according to requirements including labelling review
- Lead internal stakeholder and TGA interactions and responses in relation to regulatory queries
- Work with New Zealand distributors to support MEDSAFE listings and other regulatory reporting requirements in NZ
- Collaborate with Global Regulatory Affairs team and other key industry bodies on RA continuous improvement projects and upcoming regulatory changes to ensure timely implementation
- Lead or represent RA on assigned cross-functional project teams and provide regulatory advice
- Collaborate with Sales, Marketing, Operations and Tech Service in relation to new product launches, End of Sales/Service and support commercial Tender submissions
- Review Promotional and advertising materials
- Provide training and support to team members on quality and regulatory matters
- Assist the RAQA Manager in the day-to-day operations of the Quality Management System covering management reviews, management of product complaints, nonconforming products, CAPA, internal and external audits, quality records control, training and supplier controls, in order to maintain certification to ISO9001
- Lead internal and external audits.
- Support MDSAP and manufacturer notified body audits
- Proactively drive continuous improvement initiatives to ensure that the QMS remains relevant to continuing business growth and regulatory changes and aligned to the Corporate QMS
- Lead in the execution of strategies and innovative solutions to any potential Quality, Regulatory and Compliance issues
- Support Supplier Quality team in the execution of supplier audits, Supplier Quality Agreements, relationship manager in relation to quality-related issues
- Review Distributor agreements and Quality Agreements for Commercial teams
- Coordinate product hold, rework and release including communication with Legal manufacturers
- Collaborate with Operations teams, customer facing employees and global post market and QA teams to ensure customer complaints are dealt with effectively, in a timely manner and incompliance to regulatory expectation
- Oversee Technical Service QA operations.
- Support Hillrom learning management system administrator responsibilities for the ANZ business.
- Other duties may be assigned as required.

**Key Requirements of the role include**:

- Bachelor's degree in a relevant field
- Minimum 3 years experience in the Medical Devices industry is desirable
- In-depth knowledge of quality management systems and regulatory requirements
- Strong analytical and problem-solving skills
- Excellent communication and collaboration abilities
- Attention to detail and a commitment to accuracy
- Demonstrated ability to thrive in a high-energy and time-sensitive work setting.

**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. Baxt

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