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.

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:

Bachelors degree in science (biology chemistry microbiology immunology medical technology pharmacy pharmacology biomedical engineering) math engineering or medical fields with 4-5 years experience OR

Masters 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 employeeswho 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 governments 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 employeesstart 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 candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates 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

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.

Remote Work :

No

Employment Type :

Full-time