Sr. Manager, Regulatory Affairs
Req #: JR - 180612
Location: Deerfield, Illinois, United States
Job Category: Regulatory Affairs
Date Posted: 08/20/2025
Company Overview
At Baxter, we are united by our mission to save and sustain lives. Our products and therapies are used globally, in hospitals, clinics, and homes. For over 85 years, Baxter has pioneered innovations that transform healthcare. Here, you’ll find a place where your purpose accelerates our mission and where your work positively impacts millions of patients worldwide.
Role Overview
The Sr. Manager, Regulatory Affairs provides business, execution, and technical leadership for major, high-complexity initiatives within Baxter’s regulatory organization. This role leads multiple teams through all project phases, facilitating cross-functional collaboration with marketing, legal, quality, supply chain, manufacturing, and other stakeholders. The Sr. Manager acts as a key influencer internally and externally, managing partner expectations, regulatory compliance, and product lifecycle management processes.
Key Responsibilities
Regulatory Leadership & Strategy
Lead regulatory compliance activities related to EU MDR, EUDAMED, GUDID, UDI, SPL, and other global requirements.
Develop and implement regulatory plans aligned with business strategy for new products and ongoing product licenses/authorizations.
Lead teams to execute product submissions and regulatory approvals.
Monitor and assess new regulations, provide input on drafts, and mentor teams on regulatory initiatives.
Define regulatory strategies and make sound regulatory decisions with clear justification.
Act as an advocate for product lifecycle management processes and ensure alignment with business objectives.
Cross-Functional Collaboration
Facilitate cooperation across functions including Marketing, Legal, Quality, Supply Chain, Manufacturing, and PMOs.
Communicate proactively within Regulatory Affairs (RA) and with business partners to ensure effective coordination.
Manage risks by identifying key regulatory risks and implementing mitigation plans.
Anticipate and resolve conflicts to achieve mutually beneficial outcomes.
Support business collaborators by understanding challenges and recommending regulatory or business solutions.
Team Leadership & Development
Mentor and coach regulatory teams, fostering continuous improvement.
Lead regulatory activities related to a portfolio of products.
Provide clear direction on product lifecycle management and regulatory compliance expectations.
Qualifications & Experience
Minimum MBA/MS or Bachelor's degree with equivalent experience.
10-15 years of experience, including at least 5 years in regulatory affairs within the medical products industry.
Demonstrated success leading multi-site, global, or enterprise-wide regulatory initiatives.
Strong business acumen and leadership skills.
Experience with medical device industry and regulatory compliance is a plus.
Role model for Vital Behaviors and Leadership Essentials.
Compensation & Benefits
Estimated base salary range: $136,000 to $187,000 annually (subject to market, location, skills, and experience).
Eligibility for discretionary bonuses.
Comprehensive US benefits including:
Medical, dental, life, accident, and disability insurance (effective day one)
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan with company match
Flexible Spending Accounts
Paid holidays, PTO (20-35 days depending on tenure), family and medical leave, parental leave
Employee Assistance Program (EAP), childcare benefits, commuting benefits, and employee discounts
Work Authorization
Applicants must be authorized to work for any employer in the U.S. Baxter does not sponsor employment visas for this role at this time.
Equal Employment Opportunity
Baxter is an equal opportunity employer committed to diversity and inclusion. All qualified applicants will be considered without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, veteran status, disability, or other protected characteristics.
Reasonable Accommodations
Baxter is committed to providing reasonable accommodations to applicants with disabilities throughout the hiring process. Requests can be submitted [here].
Recruitment Fraud Notice
Beware of employment scams impersonating Baxter employees or recruiters. Protect yourself by reviewing Baxter’s Recruitment Fraud Notice.
Location
1 Baxter Parkway
Deerfield, IL 60015
United States of America
How to Apply
Click Apply Now to submit your application.
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