Global Regulatory Affairs Senior Associate — Medical Devices

ICU Medical; Lake Forest (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

ICU Medical seeks a seasoned Regulatory Affairs professional to provide global and US registration expertise for electro-mechanical device products. You will analyze requirements, prepare registration dossiers, ensure documentation compliance, and support regulatory strategy with cross-functional teams.

You will liaise with regulatory agencies, evaluate manufacturing changes for regulatory impact, and represent Global Regulatory Affairs at R&D meetings.

Qualifications

• Bachelor’s degree in a science or engineering field is required.
• Seven plus years of experience in Medical Products Industry with at least 3 years in Regulatory Affairs.
• Strong written and oral communication, project management, and cross-functional collaboration.

Responsibilities

• Provide regulatory advice and support to assigned products and teams.
• Plan and organize registration packages for device products.
• Liaise with regulatory agencies and prepare meeting materials.
• Evaluate changes for regulatory impact across regions.
• Represent Global Regulatory Affairs in R&D meetings.

Skills

Regulatory affairs

Regulatory strategy

Medical devices

Regulatory submissions

Project management

Analytical thinking

Communication skills

Education

Bachelor’s degree in science/engineering

Master’s degree or PhD preferred

RAC Certification preferred

Job description

ICU Medical seeks a seasoned Regulatory Affairs professional to provide global and US registration expertise for electro-mechanical device products. You will analyze requirements, prepare registration dossiers, ensure documentation compliance, and support regulatory strategy with cross-functional teams.

You will liaise with regulatory agencies, evaluate manufacturing changes for regulatory impact, and represent Global Regulatory Affairs at R&D meetings.