ICU Medical · 2 days ago
Associate II, Regulatory Affairs - hybrid
Lake Forest, IL
Full-time
Hybrid
Entry Level
2+ years expICU Medical is a global market leader in IV therapy and critical care products. They are seeking an Associate II in Regulatory Affairs to provide regulatory support and guidance for the registration of device products, ensuring compliance with local and global regulations.
Health CareMedical Device
Responsibilities
Drives projects forward and executes agreed upon strategies and plans with oversight. 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, understand and respond to regulatory agency correspondence
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
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
Understand global regulations and assure regulatory compliance, minimizing development costs and cycles
Prepare and maintain 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 letters
Follows scientific arguments, identifies regulatory scientific data needs and 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 with minimal oversight on routine issues, makes judgment and executes in alignment with regulatory management
Qualification
Required
Bachelor's Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject
A minimum of two years of experience in Medical Products Industry in Regulatory Affairs
Able to assess 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 engage cross functional team members
Must be at least 18 years of age
Preferred
RAC Certification preferred
Company
ICU Medical
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
Founded in 2019San Clemente, California, USA
5001-10000 employees
H1B Sponsorship
ICU Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (24)
2024 (14)
2023 (27)
2022 (31)
2021 (12)
2020 (14)
Funding
Current Stage
Late StageTotal Funding
$1.3M2012-08-15Undisclosed· $1.3M
Leadership Team
Allison Knight
Human Resources Business Partner
Ben Sousa
Chief Information Officer
Company data provided by crunchbase