Regulatory Affairs Manager (Open To Remote)

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 physiological monitoring and interoperable medical devices for the Medication Delivery global business unit (GBU).

You 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 individual contributor position within the Medication Delivery Regulatory Team and you will be accountable for the relationship with the US Food and Drug Administration and Notified Body for assigned products. You will provide input and help influence global regulatory strategies and be responsible for the execution of Baxter’s regulatory initiatives.

Responsibilities

• Ability to lead and coach others on project teams and within RA
• Ensure regulatory strategies are aligned with business objectives and project scope
• Ability to manage complex projects and timelines in a matrix team environment
• Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
• Ability to independently identify compliance risks and escalate when necessary
• Strong oral and written communication and presentation skills. Demonstrated interpersonal skills including strong negotiation skills
• Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations including development of sound regulatory decisions and justifications
• Represent and lead the RA function on assigned cross-functional project teams
• Create and maintain EU STED and Declaration of Conformity Files according to MDR
• Effectively communicate with peers and functions at the project level, within RA and with different levels of management
• Prepare and submit pre-subs, 510(k)s according to FDA guidelines
• Excellent writing skills to develop clear and logical information and conclusions based on design documentation

Qualifications

• Ability to manage complex projects and timelines in a matrix team environment
• Successful preparation and submission of 510(k)s and international documents or registrations
• Experience with software as a medical device desirable
• Ability to lead and coach others
• Strong oral and written communication and presentation skills. Demonstrated interpersonal skills including strong negotiation skills
• Scientific and sound regulatory knowledge
• At least 8 years of regulatory experience with recent physiological monitoring and interoperable medical device experience preferred; other electromechanical medical device experience will be considered
• Bachelor’s degree in a scientific discipline, engineering preferred
• Ability to independently identify compliance risks and escalate when necessary
• Excellent writing skills to develop clear and logical information and conclusions based on design documentation
• Knowledge of IEC 62034 software development lifecycle and experience in device interoperability preferred

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $80,000 to $180,000, plus an annual incentive bonus. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

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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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