Sr. Specialist Regulatory Affairs

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.

Essential Duties and Responsibilities

• Create and Review regulatory documentation for Drug, Device and Combination product renewals with major focus on Medical Device renewals.
• Interact with non-regulatory support groups (i.e., manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals
• Track status and progress of regulatory documentation that will be used for renewals
• Coordinate and compile responses to regulatory authority renewal questions (under supervision)
• Use an electronic document management system to compile documents to support product renewals for submission to Health Authorities
• Answer internal queries for assigned products
• Maintain Database of Regulatory Requirements for renewals

Qualifications

• Knowledge of regulations. Medical Device registration/renewal experience preferred.
• Scientific knowledge
• Administrative and project management skills
• Ability to contribute to multiple projects from a regulatory affairs perspective
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Technical system skills (e.g. word processing, excel, SmartSheet, databases, online research)
• Proofreading and editing skills
• Ability to independently identify compliance risks and resolve or escalate as necessary

Education and/or Experience

• Regulatory experience within a healthcare environment.
• Bachelor’s degree or country equivalent in a relevant scientific discipline.
• Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification.

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.