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[...] position will be responsible for supporting all regulatory activities associated with product development, new registrations and optimal lifecycle management of Baxter Renal Care software products. This position will interface with key business and cross-functional stakeholders to ensure that the commercial objectives are achieved. Specific activities may include submission planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project teams.
This is an important position within the Renal Care Regulatory Team, and is accountable for the relationship with the US Food and Drug Administration, along with other relevant regulatory bodies. It provides input and helps influence global regulatory strategies and is responsible for the local execution of Baxter’s regulatory initiatives in line with business goals.
Essential Duties and Responsibilities
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.
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Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.