Regulatory Affairs Specialist, Advanced Surgery

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

An 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 Responsibilities

• Compile and submit, in a timely manner, regulatory submissions for medical devices according to requirements

• Lead regulatory activities relating to specific portfolio of products / projects with minimal supervision

• Evaluate technical and scientific information, identify deficiencies, implement and complete strategies to remediate risks

• Provide regulatory advice to project teams

• Monitor applicable regulatory requirements; assure compliance with Baxter and external standards

• Prepare and follow up submissions for new products and variations in accordance with relevant guidelines, legislations and SOPs

• Analyse the scientific content of selected new registration packages to ensure they align with government regulations prior to submission

• Keep up to date with changes to regulations and standards, and advise management of the implications of such changes

• Ensure accurate documentation in compliance with QMS requirement

• Support the regulatory activities relating to specific portfolio of products

• Liaison 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 field

• A minimum of 3 years hands-on Regulatory Affairs experience of filing and handling TGA submissions for medical devices is highly desirable

• Good knowledge of relevant regulatory guidelines and regulations

• Experience in preparing and filing TGA submissions for Class III medical devices is preferred

• Ability to identify compliance risks and raise when necessary

• Ability to exercise independent judgment

• Strong written and verbal communication skills

• Experience and proficiency with MS Office word processing, spreadsheet, presentation, and Document Management Systems

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.

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