This is where you save and sustain livesAt 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.About BaxterBaxter provides a broad portfolio of essential Renal and Hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anaesthetics; and pharmacy automation, software and services.The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.The RoleAn exciting opportunity has arisen for a Regulatory Affairs Specialist to join our business. In this role you will play a critical part in supporting our Healthcare Systems and Technology business. Reporting to the Regulatory Affairs Manager, you will lead and handle activities such as acquiring and maintaining marketing authorisations for products in Australia and New Zealand (ANZ), and communication of general regulatory requirements in support of licensing of Baxter’s products.To be successful in this role you will be an experienced RA professional with the ability to think strategically and critically evaluate risks to regulatory activities, taking account of external trends in both regulatory and business environment. You would have gained this experience looking after medical device product portfolios and possess strong negotiation skills and experience in interacting with regulatory authorities, industry associations, internal and external collaborators. If you are a hard-working regulatory professional looking to make a significant impact on patient lives, we’d love to hear from you!Key ResponsibilitiesCompile and submit, in a timely manner, regulatory submissions for medical devices according to requirementsLead regulatory activities relating to specific portfolio of products / projects with minimal supervisionEvaluate technical and scientific information, identify deficiencies, implement and complete strategies to remediate risksProvide regulatory advice to project teamsMonitor applicable regulatory requirements; assure compliance with Baxter and external standardsPrepare and follow up submissions for new products and variations in accordance with relevant guidelines, legislations and SOPsAnalyse the scientific content of selected new registration packages to ensure they align with government regulations prior to submissionKeep up to date with changes to regulations and standards, and advise management of the implications of such changesEnsure accurate documentation in compliance with QMS requirementSupport the regulatory activities relating to specific portfolio of productsLiaison with local Baxter marketing colleagues and Corporate Regulatory Affairs and other colleagues to ensure open and up to date communication of the status of products and projects and relevant regulatory requirements (including change control).Key Requirements of the role include:Tertiary qualification in medical science, biotechnology, pharmacy or related scientific fieldA minimum of 3 years hands-on Regulatory Affairs experience of filing and handling TGA submissions for medical devices is highly desirableGood knowledge of relevant regulatory guidelines and regulationsExperience in preparing and filing TGA submissions for Class III medical devices is preferredAbility to identify compliance risks and raise when necessaryAbility to exercise independent judgmentStrong written and verbal communication skillsExperience and proficiency with MS Office word processing, spreadsheet, presentation, and Document Management SystemsWhy Baxter?At Baxter ANZ, we are passionate about 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 passionate about 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 AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter 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 .
