Regulatory Affairs Manager, Advanced Surgery

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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.

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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

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