Sr. Manager, Regulatory Affairs

10-15 years years

$136,000 to $187,000 annually

Deerfield

10 Sept. 3, 2025

Job Description

Job Type: Full Time Education: Minimum MBA/MS or Bachelor's degree with equivalent experience. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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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