- Act as the 'Sponsor' contact in Australia for TGA, ERAC and other applicable regulatory bodies
- Compile and submit, in a timely manner, regulatory submissions according to requirements including labelling review
- Lead internal stakeholder and TGA interactions and responses in relation to regulatory queries
- Work collaboratively 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 guidance and coaching for areas of responsibility to junior team members
- 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.
- Lead in the integration of Hill-rom and Welch Allyn with Baxter Healthcare
- Other duties as directed by RAQA Manager
- Tertiary degree in Science or related fields
- 5 years or more experience working in Quality and 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.
Senior QARA Specialist - Old Toongabbie, Australia - Baxter
Description
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 Senior RAQA Specialist to join our RAQA team at Baxter. Reporting to the Regulatory Affairs and Quality Manager you will work collaboratively on regulatory activities in ANZ focusing on preparing regulatory submissions for TGA and MedSafe listing, annual registration reviews, manufacturer evidence maintenance, regulatory database maintenance, commercial releases, regulatory changes, handling post market surveillance issues and adverse event reporting.
If you are a passionate regulatory/quality 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:
Key Requirements of the role include:
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 committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
Situated in Western Sydney, and featuring and onsite cafeteria and café, gym, we offer a dynamic and future focused work environment offering workplace flexibility, development & career growth, volunteering leave, 12 weeks parental leave, income protection insurance and a strong value driven culture focused on diversity, equality, and inclusion.