Regulatory Operations Specialist

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.

Qualifications

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
• 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