Senior 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.

• Experienced inmedical devices

• With direction, develop and execute regulatory project plans

• Identify and elevate key areas of regulatory risk

• Maintain current knowledgeof international regulatory requirements, guidance and standards applicable to company products

• Participate as an active team member and provide regulatory advice to project teams as required

• Respond to questions from regulatory authorities within strict timelines

• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements

• Maintain and update existing regulatory authorizations

• Support regulatory activities relating to specific portfolio of products/projects

• Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations

• Prepare SOPs to reflect specific local requirements.

• Review advertisement and promotional literature when needed

• Represent or lead Regulatory Affairs in small project teams

• Provide guidance to junior team members when needed

• Perform other duties as assigned

• Documentation control and maintenance of records (record retention) and ensure compliance with Regulatory Requirements, Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).

• Oversee documentation to ensure completion of records and GDP Compliance

• Prepares SOP, Document Change Request (DCRs) and Periodic Review.

• Ensure compliance with SOPs, quality assurance, internal and local regulations and GDPMDS (GDP for Medical Devices) standards.

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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