Raqa Specialist

Description:

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

We have an exciting opportunity for a RAQA Specialist to join our RAQA team at Baxter for a 6 month fixed term role. Reporting to the Regulatory Affairs and Quality Manager you will work collaboratively with the Operations, Quality and Supply Chain teams, enabling timely delivery of fully compliant products and processes as per the ANZ Commercial Business Plan.

With a key focus on Regulatory, your role will include working on effective management of the Quality Management Systems, management reviews, management of product complaints, nonconforming products, CAPA, internal audits, quality records control, training and supplier controls, in order to maintain certification to ISO9001. If you are a passionate regulatory 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:

Manage regulatory activities to portfolio of products / projects with minimal supervision

Maintain and update existing regulatory authorisations including but not limited to preparing regulatory submissions for TGA and MedSafe listing, annual registration reviews, manufacturer evidence maintenance, regulatory database maintenance and commercial releases

Respond to regulatory authorities’ questions with strict deadlines

Develop and initiate regulatory project plans and strategies

Provide regulatory impact assessments for changes to existing products and processes, new regulations and updates to standards including project planning, developing regulatory strategies, communicate country-specific requirements, forecast approval timeliness and minimise risk and time to product launch

Drive the complaint and feedback handling systems. Co-ordinate the investigation of patient incidents and as required the filing of device incident reports to regulatory bodies

Review and approve labelling/promotional/advertising materials (AdProm), change order assessment and approval, and other documents to ensure compliance to the appropriate regulations

Assist QARA Manager in the day-to-day operations of the Quality Management System including but not limited to: management reviews, management of product complaints, nonconforming products, CAPA, internal and external audits (ISO and MDSAP), quality records control, training and supplier controls, in order to maintain certification to ISO9001

Ensure the maintenance of licences and permits where applicable

Act as a contact person for all inquiries pertaining to registrations and tender requests.

Key Requirements:

Tertiary degree in Science or related fields

5 years or more experience working in 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.

Baxter is proud to be recognized as an Inclusive Employer by the Diversity Council of Australia. We are also committed to 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 all people at work.

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.

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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 here and let us know the nature of your request along with your contact information.

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