Regulatory Operations Specialist

About the job

Job Description

Primary Function of Position:

• Provide regulatory and operational support for new country product launches, global new site registrations and site renewals for Intuitive and Third-party sites

• Prepare Standardized Technical Documentation for medical devices to be used across submissions globally

• Assist with Intuitive facility transfers and manufacturing line transfer projects

• Communicate cross-functionally, including corporate departments and global departments, to improve regulatory tools and corporate processes that may impact or are related to regulatory

• Draft and update regulatory department procedures and work process tools to promote efficiency and productivity. These may include templates, forms, SOPs, work instructions, checklists, trackers, etc.

• Review procedures and identify process improvements based on data and user experience

• Collaborate with development teams to help design tools and applications for Regulatory processes and workflows

• Support audit team in preparing documents for use in audits

Essential Job Duties:

• 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. These may include templates, forms, SOPs, work instructions, checklists, trackers, etc.

• Review procedures and identify process improvements based on data and user experience.

• Assist with Intuitive facility transfers and manufacturing line transfer projects.