Senior Associate, Regulatory Affairs (Hybrid - Lake Forest, IL)

About 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.

Responsibilities

• 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 and accurately describes these changes for ease of regulatory agency review.
• Works with region and country RA counterparts to evaluate changes for regulatory impact and ensure compliance with applicable regulations.
• 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 and approves critical documents, seeking guidance when necessary.
• Reviews technical reports and determines acceptability for regulatory submission.
• Identifies registration documentation deficiencies and works with colleagues to resolve them.
• Interprets global regulations and assures regulatory compliance, minimizing development costs and cycles.
• Defines and negotiates regulatory strategy with supervision.
• Tracks and completes assigned registration activities, ensuring accuracy and meeting multiple, simultaneous deadlines.
• 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 and reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution.
• Acts independently on all routine issues, makes judgments, and executes.

Requirements

• 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 Ph.D. preferred.
• RAC Certification preferred.
• Seven plus years of experience in the Medical Products Industry with a minimum of 3 years of experience in Regulatory Affairs.
• Able to lead scientific arguments and apply analytical and logical reasoning.
• Ability to effectively 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 the ability to establish direction and influence cross-functional team members.

Work Environment

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.

About Us

ICU Medical has consistently provided clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. Our focus allows us to bring you dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization, the industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs, IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction, and significant US IV solutions manufacturing and supply capabilities.