Regulatory Affairs Specialist

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.

THISISWHEREyoubuild trust to achieve results.

What you'll be doing:

• Serve as a consultant to managers. Lead regulatory activities relating to a specific portfolio of products/projects in a country.

• Lead and manage the regulatory affairs activities for the assigned product portfolio

• Develop and implement regulatory strategies to ensure adherence to local regulations and laws

• Collaborate with cross-functional teams to acquirevital approvals for productregistrationsand maintain existing licenses.

• Prepare and submit regulatory submissions to health authorities and provide support during audits and inspections.

• Stay updated with the latest regulatoryrequirementsand industry trends to providementorship and ensure flawless execution.

• Collaboratecloselywith regional and global regulatory teams to align strategies and exchange practical approaches.

• Support the Legal Manufacturer (BHSA) in its fulfilment of its regulatory responsibilities under the MDD and MDR.

• Support BHSA and other Baxter legal manufacturers in CE mark related regulatory activities in front of the Notified Bodies and relevant Competent Authorities.

What you'll bring:

• Degree in a relevant scientific field

• Experienced specialistinRegulatoryaffairs within the medical device or pharmaceutical industry

• Proventrackrecord of successfullyimplementing regulatory strategies and acquiring product registrations

• Solidunderstanding of regulatoryrequirementsand processes

• Excellent communication and interpersonalskills

• Experienced using systems such as Trackwise / TCU document control / RIM Vault

• Ability to work independently and collaborate effectively in a cross-functional teamenvironment

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

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