ICU Medical · 13 hours ago
Associate II, Regulatory Affairs
San Diego, CA
Full-time
Hybrid
Entry, Mid Level
$64K/yr - $91K/yr
2+ years expICU Medical is a global leader in clinical innovations for IV therapy and critical care products. They are seeking an Associate II in Regulatory Affairs to provide regulatory support, ensure compliance with submission requirements, and assist in the creation of global registration dossiers.
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 regional regulatory requirements and guidelines
With oversight, understand and respond to regulatory agencies or notified body correspondences
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
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
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
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
Reviews regulatory commitments, strategy decisions, meeting strategies with regulatory authorities and changes to resource allocations with manager prior to execution
Work on special projects as assigned
Qualification
Required
Proven strong understanding of FDA, EU and worldwide submission requirements
Proven strong record of preparing regulatory submissions and obtaining approvals
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
Advanced experience with assembling global dossiers
Two to four years of medical device industry experience with regulatory affairs with direct FDA and global submission experience and authoring CE technical documentation
Strong understanding of 21 CFR 820 and ISO 13485:2016 requirements
Well-developed experience working directly with regulatory agencies. Sound knowledge of applicable portions of agency regulations and applicable guidance documents
Advanced ability to critically assess scientific arguments
Excellent oral and written communication skills
Strong problem-solving skills
Excellent interpersonal skills
Well-developed negotiating skills. Strong understanding of business needs
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 regulatory and business needs with ability to engage cross functional team members
Understanding of regulatory and business needs with ability to establish direction and influence cross functional team members
Preferred
RAC Certification preferred
Benefits
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
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