Global Regulatory Operations Specialist - Medical Devices

Intuitive; California; On-site; USD 70,000 - 110,000; Full time

Job summary

Intuitive, a global leader in robotic-assisted surgery, seeks a Regulatory Operations professional to provide regulatory and operational support for new country product launches, site registrations, and renewals worldwide.

The role involves preparing standardized technical documentation, collaborating with cross-functional teams, and updating procedures to improve efficiency and productivity within regulatory workflows.

Qualifications

• Bachelor's degree in science, math, engineering or medical fields with 4-5 years' experience OR Master's degree with 1-2 years' experience.
• Essentials of Data Structure and Algorithms, Software Design and Architecture.
• Strong attention to detail and ability to follow procedures, processes, and instructions.

Responsibilities

• Collaborate with development teams to help design tools and applications for Regulatory processes and workflows
• Draft and update regulatory department procedures and work process tools to promote efficiency and productivity.
• Review procedures and identify process improvements based on data and user experience.
• Assist with Intuitive facility transfers and manufacturing line transfer projects.

Job description

Intuitive, a global leader in robotic-assisted surgery, seeks a Regulatory Operations professional to provide regulatory and operational support for new country product launches, site registrations, and renewals worldwide.

The role involves preparing standardized technical documentation, collaborating with cross-functional teams, and updating procedures to improve efficiency and productivity within regulatory workflows.