Sr. Manager, Regulatory Affairs

2 weeks ago

Round Lake IL, United States Baxter International Full time

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. What you will doAs a Sr. Manager - Global Regulatory Affairs, you will be responsible for developing strategic global regulatory plans and preparing 510(k) submissions in support of new and existing marketing authorizations for infusion pumps.This is a meaningful individual contributor position within the Infusion Therapies and Technologies Regulatory Team and you will be accountable for the relationship with the US Food and Drug Administration and Notified Body for assigned products. Specific activities may include submission planning, creation of 510(k) submission documentation and pre-subs, coordinate, and lead meetings with FDA.You will evaluate technical and scientific information to manage and maintain operational activities in support of regulatory decisions and existing marketing authorizations. Specific activities may include identification of local submission requirements, product/facility change management, process support, and participation in project teams. You will provide input and help influence global regulatory strategies and be responsible for the execution of Baxter’s regulatory initiatives. You will supervise, evaluate, and interpret applicable regulatory requirements, assure compliance with Baxter and external standards as well as assess impact of new regulations. You will interface with key business and cross-functional stakeholders and maintain appropriate communication within the RA function, with Marketing, and with other functions primarily at the project team level. What do you bringBachelor’s degree in a scientific discipline, engineering preferred.At least 7 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.Expert regulatory knowledge and sound scientific skills.Ability to manage complex projects and timelines in a multinational/multicultural 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.Identify and prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans.Ability to lead and mentor others.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 employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $128,000 to $176,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. 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 OpportunityBaxter 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.EEO is the Law EEO is the law - Poster SupplementPay Transparency PolicyReasonable AccommodationsBaxter 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 NoticeBaxter 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.SummaryLocation: Round Lake, IllinoisType: Full time

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