Regulatory Affairs Manager, Advanced Surgery at Baxter International Inc.

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

22 Jan, 26

Salary

0.0

Posted On

24 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Device, Pharmaceutical Industry, Regulatory Compliance, Strategic Projects, Communication Skills, Problem-Solving, Attention to Detail, Regulatory Information Management, Leadership, Mentoring, Risk Management, Project Management, Labeling Compliance, SOPs, AdProm Materials

Industry

Medical Equipment Manufacturing

Description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. The Role We are seeking a highly skilled Regulatory Affairs Manager to join our Advanced Surgery business at Baxter. In this role, you will be at the forefront of crafting and enacting regulatory strategies for our Advanced Surgery portfolio. You will coordinate regulatory initiatives across Australia and New Zealand, while also leading all aspects of broader strategies within the APAC region, excluding Japan and China. Reporting to the Senior Director, Regulatory Affairs, your key accountabilities will include ensuring regulatory compliance with relevant requirements and guidelines, providing guidance on strategic projects and initiatives, and developing and justifying sound regulatory decisions that support business objectives. Additionally, you will be responsible for managing effective communication and relationships with ANZ regulatory authorities, as well as providing regulatory guidance and support to the Advanced Surgery commercial business operations within the region. Key Responsibilities Develop and implement regulatory strategies for intricate projects, covering new products and maintaining licenses for existing products in ANZ Develop and put into effect regulatory strategies for the APAC region (excluding Japan and China) Identify and prioritize key areas of risk, developing and implementing appropriate mitigation plans Monitor applicable regulatory requirements to ensure compliance with Baxter and external standards Perform gap analysis on regulatory documentation, proposing solutions and identifying areas for improvement Establish effective communication within the Regulatory Affairs (RA) department, with local Marketing, and other functions primarily at the project level, promoting proactive communication Ensure regulatory strategy and deliverables are aligned with project teams and business objectives Manage regulatory tasks for the Advanced Surgery product portfolio Prepare, review, and approve labeling, SOPs, and AdProm materials for compliance with ANZ regulations Supervise the operational elements of the Regulatory Information Management system, covering registrations, submissions, and data lifecycle management Represent or lead the RA function on assigned cross-functional project teams Lead all aspects of and coordinate regulatory actions for Advanced Surgery in the APAC region (excluding Japan and China) Serve as the face of Regulatory Affairs within the Advanced Surgery VP of APAC’s leadership team. Key Requirements 5-10 years experience in regulatory affairs within the medical device or pharmaceutical industry Solid understanding of ANZ regulatory requirements and familiarity with APAC region regulations Masters' degree/PhD in a relevant field; advanced degree or equivalent experience is a plus Exceptional proficiency in crafting and implementing compliance plans for intricate projects Excellent communication and interpersonal skills to work effectively within cross-functional teams Demonstrated ability in problem-solving and effectively handling various tasks Excellent focus on details and the capability to operate autonomously Working experience with Regulatory Information Management systems is desirable Strong Technical and management skills Ability to lead and mentor others Ability to independently identify compliance risks and escalate when necessary. 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. #li-baxgen #LI-JB1 #ind-anz Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. 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. Recruitment Fraud Notice Baxter 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 Recruitment Fraud Notice. No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.

Responsibilities

Develop and implement regulatory strategies for new and existing products in the Advanced Surgery portfolio. Coordinate regulatory initiatives across Australia and New Zealand and lead broader strategies within the APAC region.