Regulatory Affairs Manager

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. 

As a Manager - Global Regulatory Affairs, you will be responsible for defining global regulatory strategies and preparing 510k submissions in support of new and existing marketing authorizations for infusion pumps.

Responsibilities

• Develop and execute regulatory plans for infusion pumps, infusion pump platforms and connected devices for new products. Obtain marketing authorizations for assigned regions and support local country submissions. Develop sound regulatory decisions and justifications.

• Monitor applicable regulatory requirements; assure compliance with internal and external standards

• Ensure regulatory strategies are aligned with business objectives and project scope

• Represent and lead the RA function on new infusion pump development programs

• Prepare and submit pre-subs, 510(k)s according to FDA guidelines

• Create and maintain EU STED and Declaration of Conformity Files according to MDR

• Excellent writing skills to develop clear and logical information and conclusions based on design documentation

• Strong oral and written communication and presentation skills. Demonstrated interpersonal skills including strong negotiation skills

• Effectively communicate with peers and functions at the project level, within RA and with different levels of management

• Ability to manage complex projects and timelines in a matrix team environment

• Ability to independently identify compliance risks and escalate when necessary

• Ability to lead and coach others on project teams and within RA

Qualifications

• Bachelor’s degree in a scientific discipline, engineering preferred

• At least 5 years regulatory experience with recent infusion pump experience preferred; other electromechanical medical device experience will be considered

• Successful preparation and submission of 510(k)s and international documents or registrations

• Knowledge of IEC 62304 software development lifecycle and experience in device interoperability preferred

• Experience with software as a medical device desirable

• Scientific and sound regulatory knowledge

• Ability to manage complex projects and timelines in a matrix team environment

• Strong oral and written communication and presentation skills. Demonstrated interpersonal skills including strong negotiation skills

• Excellent writing skills to develop clear and logical information and conclusions based on design documentation

• Ability to independently identify compliance risks and escalate when necessary

• Ability to lead and coach others

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#IND-USOPS

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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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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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