Regulatory Operations Specialist

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.
Required Skills and Experience:
Minimum 0-2 years relevant experience working in a medical device company; preferred 1-2 years of experience working in regulatory operations or software development
Essentials of Data Structure and Algorithms, Software Design and Architecture
Strong attention to detail and ability to follow procedures, processes, and instructions
Good communication (written and oral) and organizational skills
Ability to perform multiple tasks in a fast-paced environment
Motivated to excel and work in a team environment
Excellent customer service and interpersonal skills
Ability to deal with problems/issues in a professional manner
Understand implications of work and make recommendations for improvements in processes
Excellent skills in MS Word, Excel, and Outlook; capacity to learn additional software
Identifies and solves basic problems
Experience in writing Technical specifications, User Requirements, Functional Requirements preferred, but not required
Required Education and Training:
Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, biomedical engineering), math, engineering, or medical fields with 4-5 years’ experience OR
Master's degree or foreign equivalent in Biomedical Engineering, Regulatory Science, Life Science, Pharmacy, or a related field with 1 – 2 years’ experience.
Working Conditions:
None
Preferred Skills and Experience:
Strong attention to detail and ability to follow procedures, processes, and instructions
Understand implications of work and make recommendations for improvements in processes
Excellent skills in MS Word, Excel, and Outlook; capacity to learn additional software
Good communication (written and oral) and organizational skills
Ability to perform multiple tasks in a fast-paced environment
Motivated to excel and work in a team environment
Experience in writing Technical specifications, User Requirements, Functional Requirements preferred, but not required
Essentials of Data Structure and Algorithms, Software Design and Architecture

Employment type
Full-time

Work arrangement
Hybrid