Regulatory Affairs Manager

ICU Medical

Regulatory Affairs Manager overseeing regulatory operations, documentation, and submissions at ICU Medical. Engaging with regulatory agencies and cross-functional teams to ensure compliance and successful product registration.

Posted 7/21/2026full-timeLake Forest • Illinois • 🇺🇸 United StatesSeniorLead💰 $112,500 - $161,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs within the Medical Device industry, with a strong focus on managing regulatory operations, developing global regulatory strategies, and ensuring compliance with regulatory agencies. Proven leadership in overseeing regulatory submissions and managing cross-functional teams.

Highest-signal resume keywords

Regulatory Affairs ManagementMedical Device Industry ExperienceRegulatory Submissions PreparationRegulatory Inspections ExperienceTeam Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Data ManagementRegulatory Strategy DevelopmentProduct RegistrationDocumentation ReviewRegulatory Compliance

Soft Skills

Cross-Functional CollaborationInterpersonal CommunicationLeadership

Industry Keywords

Regulated IndustryRegulatory OperationsRegulatory AgenciesProduct RegistrationsRegulatory Submission Packages

About the role

Key responsibilities & impact

Manages the Regulatory Operations team responsible for various operational regulatory activities.
Oversee the preparation, review and submission of data and documentation to support regulatory applications, product registrations.
Establishes and manages systems and processes to support publishing of regulatory submission packages, product and facility registrations and regulatory data management.
Provides regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensuring that it is effectively presented for the registration of products.
May serve as a lead regulatory representative to an assigned product or project team.
Interacts with various regulatory agencies and internal ICU Medical cross functional organizations.

Requirements

What you’ll need

Must be at least 18 years of age.
Bachelor’s degree from an accredited college or university is required.
Minimum eight years of experience in Medical Device, or regulated industry, specifically three years in Regulatory Affairs
Minimum of two years’ management experience
Experience with Regulatory inspections and successful track record

Benefits

Comp & perks

Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
A wide range of benefit options at affordable rates
Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement