Manager Regulatory Affairs – Front Line Care

5+ years years

$112,000 to $154,000 annually

New York

10 Sept. 3, 2025

Job Description

Job Type: Full Time Education: Bachelor’s degree or equivalent in a scientific field; Masters and/or PhD preferred. 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

Manager Regulatory Affairs – Front Line Care (FLC)

Req #: JR - 170188
Location: Skaneateles Falls, New York, United States
Additional Locations: Raleigh, North Carolina; Round Lake, Illinois; Deerfield, Illinois; Bellevue, Washington; St Paul, Minnesota
Job Category: Regulatory Affairs
Date Posted: 07/11/2025

Company Overview

At Baxter, we are deeply connected by our mission to save and sustain lives. Our products and therapies are used globally—in hospitals, clinics, and homes. With over 85 years of pioneering medical innovations, Baxter is committed to improving outcomes for millions of patients. Join us where your purpose accelerates our mission.

Role Overview

Responsible for defining and executing global regulatory strategies and submissions to support new and existing marketing authorizations for one or more business units or countries.

Key Responsibilities

Develop and execute regulatory plans for complex projects, including new products and maintenance of licenses/authorizations for marketed products.
Represent or lead the Regulatory Affairs (RA) function on assigned cross-functional project teams.
Monitor applicable regulatory requirements and ensure compliance with Baxter and external standards.
Establish effective communication within RA and with other functions, primarily at the project level.
Perform gap analysis and propose solutions to ensure regulatory compliance.
Develop and document sound regulatory decisions and justifications.
Align project teams and business objectives with regulatory strategies and deliverables.
Provide direct supervision to team members (as applicable).
Review promotional materials or Standard Operating Procedures (SOPs) for compliance with local and global regulations (as applicable).

Qualifications & Experience

Bachelor’s degree or equivalent in a scientific field; Masters and/or PhD preferred.
5+ years of experience in Regulatory Affairs or related field (preferably medical device or pharmaceutical).
Experience with people management or project leadership.
Ability to work effectively in multinational, multicultural environments.
Strong scientific knowledge and communication skills.
Ability to manage multiple projects within a matrix team environment.
Excellent oral, written, and presentation skills.
Strong interpersonal, collaboration, and negotiation skills.
Experience with Class II and Class III EU medical devices preferred.
Experience with EU MDR and US 510(k) submissions strongly preferred.

Work Environment & Flexibility

Baxter supports flexible workplace policies, requiring a minimum of 3 days per week onsite to foster collaboration and mission support.

Compensation & Benefits

Estimated base salary: $112,000 to $154,000 annually (subject to market, location, skills, and experience).
Eligible for discretionary bonuses.
Comprehensive US benefits including:
- Medical and dental coverage starting day one
- Life, accident, short-term and long-term disability insurance
- Business travel accident insurance
- Employee Stock Purchase Plan (ESPP)
- 401(k) Retirement Savings Plan with company matching
- Flexible Spending Accounts
- Educational assistance programs
- Paid holidays and 20-35 days of paid time off (based on service length)
- Family and medical leave, parental leave
- Commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), childcare benefits

Work Authorization

Applicants must be authorized to work for any employer in the U.S. Baxter is unable to sponsor or transfer employment visas for this position.

Equal Employment Opportunity

Baxter is an equal opportunity employer and values diversity. All qualified applicants are considered regardless of 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 individuals with disabilities during the application and interview process. Requests can be submitted [here].

Recruitment Fraud Notice

Be aware of fraudulent activities involving impersonation of Baxter employees or recruiters. Protect yourself by reviewing Baxter’s Recruitment Fraud Notice.

Location Address

4341 State Street Road
Skaneateles Falls, NY 13153
United States of America

How to Apply

Click Apply Now to submit your application.

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Manager Regulatory Affairs – Front Line Care

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