Sr Manager, Regulatory Affairs

Baxter

10-12 years

$136,000 – $187,000

United States

10 Oct. 30, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Position Title: Sr. Manager, Regulatory Affairs

Req ID: JR-180612
Location: Deerfield, Illinois, United States
Job Category: Regulatory Affairs
Date Posted: August 20, 2025

🧭 Overview:

At Baxter, every employee plays a vital role in fulfilling our mission to save and sustain lives. Our products and therapies are used in hospitals, clinics, and homes around the world. For more than 85 years, Baxter has pioneered medical innovations that have transformed global healthcare.

Joining Baxter means being part of a purpose-driven team that values success, collaboration, and growth — where your contributions directly impact patient lives.

🎯 Your Role at Baxter:

The Sr. Manager, Regulatory Affairs provides business, execution, and technical leadership for major and high-complexity regulatory initiatives across Baxter’s global operations.
This position involves leading cross-functional teams through all phases of regulatory projects, collaborating with departments such as marketing, legal, quality, supply chain, manufacturing, and labeling, and interacting with regulatory authorities.
You will serve as an advocate for product lifecycle management (PLM) and ensure compliance across jurisdictions.

🧩 Key Responsibilities:

Lead teams in implementing product submissions and global regulatory strategies.
Manage regulatory compliance activities related to EU MDR, EUDAMED, GUDID, UDI, SPL, and other global requirements.
Collaborate on cross-functional regulatory initiatives to accelerate time to market.
Monitor and interpret new regulations; provide expert guidance to the organization.
Develop and implement regulatory plans aligned with business strategies for both new and existing products.
Identify and mitigate regulatory risks through proactive planning.
Ensure regulatory strategies align with overall project and business objectives.
Author and document sound regulatory decisions and justifications.
Serve as the regulatory lead throughout the product lifecycle.
Establish effective communication across internal teams and senior management.
Resolve potential conflict scenarios and manage stakeholder expectations.
Coach, mentor, and guide regulatory teams to achieve business and compliance goals.
Drive continuous improvement and business results through enhanced regulatory practices.

🧠 Qualifications & Experience:

Education:
- MBA/MS preferred, or Bachelor’s degree in a related field with equivalent experience.
Experience:
- 10–15 years total experience, with at least 5 years in regulatory affairs in the medical products or device industry.
- Demonstrated success in leading multi-site or global regulatory initiatives.
- Strong leadership, strategic thinking, and communication skills.
- Deep understanding of regulatory frameworks and product lifecycle management.
- Experience working with regulatory authorities is an advantage.
- Medical device and/or regulatory compliance background preferred.

💼 Salary & Compensation:

Estimated Base Salary: $136,000 – $187,000 per year
Final pay will depend on location, skills, experience, and market data.
Eligible for discretionary bonuses based on performance.

🌟 Employee Benefits (U.S., except Puerto Rico):

Medical, Dental, and Vision Coverage – effective from Day One
Basic Life, Accident, Disability Insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan with company matching
Flexible Spending Accounts (FSA)
Educational Assistance Programs
Paid Time Off: 20–35 days (based on tenure) + paid holidays
Paid Parental Leave and Family/Medical Leaves of Absence
Employee Discount & Assistance Programs (EAP)
Childcare and Commuting Benefits

⚖️ Equal Employment Opportunity:

Baxter is an Equal Opportunity Employer and evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, veteran status, or disability.

♿ Reasonable Accommodations:

Baxter is committed to providing reasonable accommodations to individuals with disabilities during the application and interview process.
If you require accommodation, please contact Baxter via the provided link with details of your request.

⚠️ Recruitment Fraud Notice:

Be aware of fraudulent recruitment schemes posing as Baxter representatives. Baxter never requests payment or personal financial details during recruitment. For safety tips, review Baxter’s Recruitment Fraud Notice.

📍 Work Location:

1 Baxter Parkway, Deerfield, IL 60015, United States

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Sr Manager, Regulatory Affairs

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