New · posted Oct 15
ICU Medical · Medical Devices
Senior Associate, Regulatory Affairs
- Lake Forest, IL
- Hybrid
- Full-time
- Senior & Principal
Open until filled
The role
Provides regulatory support and expertise associated with global and US registration of device electro mechanical products, including in-depth analysis of the requirements and tracking of deliverables. With oversight, supports creation of global regulatory strategies and assists in execution including creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management.
What you need
Minimum Qualifications, Education & Experience
- 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 with a minimum of 3 years of experience 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.
Knowledge & Skills
- Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission.
- Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
- Interpret global regulations and assure regulatory compliance, minimizing development costs and cycles.
- Define and negotiate regulatory strategy with supervision.
- Exercise good judgment within policy and regulations.
- Responsible for tracking and completion of assigned registration activities.
- Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letter.
- Follows scientific arguments, identifies regulatory scientific data needs and solves regulatory issues with alignment of regulatory management.
- Presents scientific data effectively orally and in writing in a logical and persuasive manner.
- Provides daily regulatory support to new product development teams and commercial support with guidance.
- Participates in preparing regulatory strategies. Reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution.
- Acts independently on all routine issues, makes judgment and executes.
What you'll do
- 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.
Pay and benefits
$97,500 – $139,750 a year
Employer providedSalary Range - $97,500 - $139,750
401(k) match
Annual Incentive Plan
Paid Time Off
Company Holidays
Tuition Reimbursement
Health and welfare benefits
Where you'll work
Lake Forest, ILHybridOpen in Maps (opens in a new tab)
More jobs in Lake Forest, ILWorking conditions
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel 5-20% of the time
The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.
ICU Medical provides a comprehensive total rewards package that includes:
- 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
Additional information on health and welfare benefit offerings can be found at https://www.icumed.com/about-us/careers/investing-in-your-future/.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 14% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Senior & Principal roles in Illinois6 roles publishing pay
Senior & Principal roles in the US53 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $97,500 | — | $139,750 |
| Illinois (middle half) | $116,000 | $121,250 | $139,625 |
| All US (middle half) | $115,000 | $137,500 | $150,000 |
This role: ICU Medical's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not ICU Medical's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Regulatory submissions7
- GMP and compliance5
- Documentation and SOPs4
- Lab testing and methods1
Company hiring pulse
ICU Medical on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 4
- Locations
By discipline
- Quality6 86%
- Regulatory1 14%
By level
- Associate & Specialist4 57%
- Senior & Principal3 43%
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Senior Associate, Regulatory Affairs at ICU Medical
Open until filled. $98K–$140K a year, employer provided.