Regulatory Affairs Specialist, Advanced Surgery

1 month ago

Old Toongabbie, Australia Baxter Full time

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.

About Baxter

Baxter 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 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

Why 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.

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.

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