Principal Specialist, Regulatory Affairs

Baxter International Inc.

. Manage regulatory approvals, registrations, and change assessments for medical device products .

Posted 10/7/2026full-timeRound Lake • Illinois • United StatesLead💰 $104,000 - $143,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing regulatory approvals and submissions for medical devices, including 510(k) filings and EU MDR documentation. Capable of developing regulatory strategies and collaborating with cross-functional teams to ensure compliance in a global market.

Highest-signal resume keywords

Regulatory Strategy Development510(k) Submission PreparationEU MDR Documentation ManagementRegulatory Impact AssessmentCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Approvals ManagementRegulatory SubmissionsChange AssessmentTechnical Documentation ReviewRegulatory KnowledgeScientific Information InterpretationProject ManagementGlobal Registrations FamiliarityElectromechanical Medical Devices ExperienceFDA Change Assessment Guidance

Soft Skills

Strong Communication SkillsNegotiation SkillsInfluencing SkillsProblem-Solving SkillsTeam Collaboration

Industry Keywords

Medical Device IndustryRegulatory AffairsNotified Bodies InteractionLifecycle ManagementMultinational Team EnvironmentComplianceRegulatory Risks Identification

About the role

Key responsibilities & impact

Manage regulatory approvals, registrations, and change assessments for medical device products
Develop regulatory strategies and submission plans for product changes, process changes, and new market introductions
Evaluate regulatory impact and submission requirements for the U.S., EU, and other international markets
Prepare and submit U.S. regulatory filings, including 510(k) submissions, pre-submissions, and responses to FDA requests
Maintain EU MDR regulatory documentation and support technical documentation updates
Support interactions with Notified Bodies and regulatory authorities
Review technical, scientific, and quality information to assess regulatory impact and support lifecycle changes
Monitor changes in regulatory requirements and assess impacts on products, processes, and regulatory strategies
Partner with Regulatory Affairs, R&D, Quality, Marketing, Operations, and international regulatory colleagues on global submissions and compliance
Support lifecycle management, timely submissions and approvals, and compliant product changes

Requirements

What you’ll need

Bachelor’s degree in scientific or engineering subject area
5 years regulatory experience in the medical device industry
Experience with electromechanical medical devices is desirable
Experience with FDA change assessment guidance and EU MDR technical documentation expectations
Ability to document regulatory decisions and defend submission strategy
Successful preparation and submission of 510(k)s
Familiarity with global registrations beyond the US and EU
Strong regulatory knowledge and ability to interpret scientific information to support regulatory submissions
Ability to influence cross-functional partners and drive regulatory alignment in a matrixed, global organization
Ability to manage multiple projects and timelines in a multinational/multicultural team environment
Strong oral and written communication and presentation skills
Strong negotiation skills
Ability to identify, prioritize, and communicate regulatory risks and raise issues when appropriate
Applicants must be authorized to work for any employer in the U.S.; Baxter is unable to sponsor or take over sponsorship of an employment visa

Benefits

Comp & perks

$5,000 sign-on bonus
Medical and dental coverage starting on day one
Basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP) with discounted company stock
401(k) Retirement Savings Plan with employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits
Flexible workplace policy with onsite and remote flexibility