Regulatory Affairs Associate

Macquarie Park, NSW
Contract
Full-time

8 days ago

JOB DESCRIPTION:About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:Career development with an international company where you can grow the career you dream of .A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.An exciting 2-year fixed term contract opportunity has come up which is ideal for candidate with foundational experience in Regulatory Affairs for Medical devices/In Vitro Diagnostics. We are looking for an extremely motivated Regulatory Affairs Associate to support On-market activities. This is cross divisional role with primary functions within Diagnostics Division. This role will provide a wide range of support activities across the Regulatory Department and will be ideal for a proactive and resilient self-starter, with excellent multi-tasking abilities and a high attention to detail. Based at our head office in Macquarie Park, this role would require you to work with a close-knit team that’s consistently working towards providing insights that enable smarter, faster decisions to transform the way the world is managing health.The main aspects of this role include:Collaborate with cross-functional teams—including marketing, sales, and logistics—to develop regulatory strategies that support on market productsPrepare and lodge regulatory submissions, including those requiring conformity assessments, for changes to on market in vitro diagnostic (IVD) products and updates to internal compliance recordsReview and evaluate the scientific integrity of submission documents to ensure alignment with regulatory standards before forwarding to the appropriate national authority.Advise global regulatory on-market teams on local compliance needs to support innovation product maintenance requirements and/or modifications.Partner with marketing to review and approve promotional content, ensuring adherence to local advertising regulations.Offer mentorship, training, and support to regulatory affairs (RA) colleagues, while leveraging data to identify and implement process improvements.Maintain a thorough understanding of ISO 9001, the Therapeutic Goods Act 1989, and the Australian Medical Devices Regulations 2002, along with other applicable federal and state laws.Monitor and assess changes to emerging regulations for on market products and communicate potential impacts to both local and global teams.Drive process updates in response to such changes, collaborating with Quality Assurance to ensure integration into the quality management system.Secure additional regulatory authorisations as needed, such as import permits and Certificates of Free Sale (CFS).Stay informed on global regulatory developments, guidance updates, and industry best practices.Provide timely regulatory intelligence and updates to leadership and cross-functional teams.Maintain regulatory documentation and records in accordance with internal procedures and regulatory requirements.Ensure all regulatory decisions and activities are accurately documented.Prepare regulatory reports and summaries for internal and external stakeholders.Participate in cross-functional projects to meet regulatory and quality goals.Promote a collaborative team culture that values open communication, diversity and shared learning.What would make you a successful candidateA degree in science, biomedical studies, or a related field.At least 2–3 years of experience in regulatory affairs within the medical device or IVD sector.Solid understanding of both Australian and international regulatory frameworks (e.g., TGA, FDA, EU IVDR).Familiarity with ISO 13485 and other relevant quality standards.Exceptional verbal, written, and interpersonal communication skills are essential for this role, as it requires frequent engagement with internal and external stakeholders, clear articulation of complex regulatory concepts, and the ability to build strong collaborative relationships across diverse teams.Ability to work autonomously and collaboratively in a dynamic environment.Exceptional attention to detail across all regulatory and quality tasks.A mindset geared toward innovation and continuous improvement.Proactive engagement with industry trends and regulatory updates.Proven ability to manage multiple projects and competing priorities.Proficiency in Microsoft Office and other standard business applicationsThe base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Regulatory OperationsDIVISION: CRLB Core LabLOCATION: Australia
Macquarie Park : 299 Lane Cove RoadADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: NoMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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