Sr Clinical Study Manager

Provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products. This person will work with confidential subjects and company data, and interface with a variety of internal and external stakeholders. The Sr. Clinical Study Manager understands business environment and relates extensive knowledge of internal and external activities to trends.

Global Regulatory Compliance Lead

The Global Regulatory Compliance Lead is responsible for leading assigned Regulatory Compliance activities, including activities related to the procedural document creation and updates, audit and inspection execution and preparation and regulatory risk management. The role will also support the Global Regulatory Affairs department with various operational quality and compliance activities, as well as training assignments and follow-up.

Associate Director, RA Global Regulatory Strategy, US & Canada

Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. Demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements. Assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs. Supports products within the Oncology TA.