Senior Associate, Regulatory Affairs

ICU Medical

Senior Associate providing regulatory support for global and US registration of medical device products. Involves in-depth analysis, tracking deliverables, and assisting in global regulatory strategies.

Posted 6/17/2026full-timeLake Forest • Illinois • 🇺🇸 United StatesSenior💰 $97,500 - $139,750 per yearWebsite

About the role

Key responsibilities & impact

Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations.
Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines.
With oversight, serves as a liaison with regulatory agencies pertaining to assigned products. Assists in the preparation of agency meeting packages and strategies for agency meetings.
Evaluates manufacturing and labeling changes for regulatory impact. Accurately describes these changes for ease of regulatory agency review.
Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team.

Requirements

What you’ll need

Must be at least 18 years of age
High School Diploma required
Bachelor’s degree from an accredited college in pharmacy, biology, chemistry, pharmacology, engineering or related subject or university is required
Master’s Degree or P.H.D preferred
RAC Certification preferred
Seven plus years of experience in Medical Products Industry in Regulatory Affairs.
Able to lead scientific arguments and apply analytical and logical reasonings.
Ability to effectively prioritize workload and multitask with minimal supervision.
Good interpersonal skills.
Good oral and written communications 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

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory adviceregistration packagesregulatory impact evaluationmanufacturing changes assessmentlabeling changes assessmentagency meeting preparationscientific argumentationanalytical reasoningproject management

Soft Skills

interpersonal skillsoral communicationwritten communicationcritical thinkingcontingency planningnegotiating skillsworkload prioritizationmultitaskinginfluenceteam collaboration

Certifications

RAC Certification