Regulatory Operations Specialist

Regulatory Operations Specialist

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

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:

• 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

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).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate's experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate's qualifications, consistent with applicable law.

Accommodation & Accessibility Notice:

Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at View email address on click.appcast.io.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.