Senior Associate, Regulatory Affairs

ICU Medical

Regulatory Affairs specialist supporting ICU Medical’s global and US registration of electromechanical medical devices. Preparing submissions, evaluating product changes, and maintaining regulatory compliance for IV therapy and critical-care products.

Posted 8/18/2026full-timeLake Forest • Illinois • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs with a strong focus on compliance, registration strategies, and effective communication of scientific data. Capable of leading regulatory representation and managing cross-functional teams to ensure adherence to local and global regulations.

Highest-signal resume keywords

Regulatory Affairs ExperienceRegistration Package PreparationRAC CertificationProject Management SkillsAnalytical Reasoning

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceRegistration StrategyDocument ReviewScientific Data InterpretationRegulatory Impact EvaluationLabeling Change AssessmentRegulatory Submission PreparationCross-Functional CollaborationNegotiation SkillsContingency Planning

Soft Skills

Interpersonal SkillsOral CommunicationWritten CommunicationCritical ThinkingMultitasking

Certifications & Qualifications

RAC Certification

Industry Keywords

Medical Products IndustryRegulatory StrategyGlobal RegulationsRegistration DocumentationRegulatory Agencies

About the role

Key responsibilities & impact

Provide regulatory advice and support to assigned products and teams
Identify and communicate registration needs and strategies
Plan and organize registration packages for device products
Prepare registration packages according to local regulatory requirements and guidelines
Liaise with regulatory agencies for assigned products under oversight
Prepare agency meeting packages and strategies
Evaluate manufacturing and labeling changes for regulatory impact
Work with regional and country Regulatory Affairs counterparts to ensure compliance
Represent Global Regulatory Affairs at research and development meetings
Present agreed regulatory positions and potentially lead regulatory representation for assigned products or projects
Review and approve critical documents and technical reports for regulatory submission
Identify registration documentation deficiencies and resolve them with colleagues
Interpret global regulations and assure regulatory compliance
Define and negotiate regulatory strategy with supervision
Track and complete assigned registration activities
Follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues
Present scientific data effectively orally and in writing
Provide daily regulatory support to new product development teams and commercial support
Participate in preparing regulatory strategies and review submissions, commitments, strategy decisions, and resource allocations with the manager
Act independently on routine issues and execute decisions

Requirements

What you’ll need

Must be at least 18 years of age
High School Diploma required
Bachelor’s degree from an accredited college or university in pharmacy, biology, chemistry, pharmacology, engineering, or a related subject is required
Master’s Degree or P.H.D preferred
RAC Certification preferred
Seven plus years of experience in the Medical Products Industry, including a minimum of 3 years of experience in Regulatory Affairs
Able to lead scientific arguments and apply analytical and logical reasoning
Ability to prioritize workload and multitask with minimal supervision
Good interpersonal skills
Good oral and written communication skills
Demonstrated project management skills
Demonstrated critical thinking, contingency planning, and negotiating skills
Understanding of regulatory and business needs, with ability to establish direction and influence cross-functional team members

Benefits

Comp & perks

Typically requires travel 5-20% of the time
Equal Opportunity Employer
Reasonable accommodation for individuals with disabilities
Equal access and opportunities for all candidates