AddressThis 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:
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.
Key Requirements of the role include:
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.
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.
We are proud to be recognised among the top 120 companies for the seventh consecutive year as an Employer of Choice for Gender Equality for 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 women at work. We are also pleased to be the winner of the 2021 & 2019 Women in MedTech Champion Company Award.
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.
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.
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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