Regulatory Affairs Manager (Hybrid - Lake Forest, IL)

Manages the Regulatory Operations team responsible for various operational regulatory activities. Oversee the preparation, review and submission of data and documentation to support regulatory applications, product registrations. Establishes and manages systems and processes to support publishing of regulatory submission packages, product and facility registrations and regulatory data management.

Provides regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensuring that it is effectively presented for the registration of products. May serve as a lead regulatory representative to an assigned product or project team. Interacts with various regulatory agencies and internal ICU Medical cross functional organizations.