eduu.fa.us2.oraclecloud.com

eduu.fa.us2.oraclecloud.com

Regulatory Affairs Manager (Hybrid)

Lake Forest, IL, United States

Sponsorship not specifiedDetected 2 days ago
FDA RegulatoryRegulatory Affairs

About the role

  • Interacts with various regulatory agencies and internal ICU Medical cross functional organizations.

Responsibilities

  • 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.

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