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. 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.

Qualifications

Required Skills and Experience:

• Some 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

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).

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