Associate Regulatory Operations Specialist

This position is part of the Regulatory Affairs Data and Product Release Group within the Medtronic Clinical & Regulatory Solutions (MCRS) organization, supporting regulatory systems and processes.

A Day in the Life

The role primarily interfaces with regulatory affairs teams, operating unit regulatory teams, regulatory operations teams, and senior managers and directors. It supports projects that enhance regulatory compliance and data integrity and fosters collaboration across global teams.

Responsibilities

• Activities related to enterprise-wide regulatory management systems, including systems coordination, training, developing and implementing plans, and providing input to systems designs.
• Performs Regulatory Operations activities including data transformation to support global Unique Device Identification (UDI) submissions.
• Collaborates with global regulatory affairs teams and operation units to gather and analyze required i...