Regulatory Operations Specialist
Intuitive Surgical
Regulatory Operations Specialist supporting medical device product launches, site registrations, and global submissions. Develops standardized technical documentation, manages facility transfers, and drives process improvements across regulatory workflows.
Responsibilities
- Support new country product launches and global site registrations and renewals
- Prepare standardized technical documentation for medical devices across global submissions
- Draft, update, and review regulatory procedures, SOPs, templates, and process improvement tools
- Collaborate with development teams to design regulatory tools and applications
- Assist with facility transfers and manufacturing line transfer projects
Requirements
- Bachelor's in science or engineering with 4-5 years experience, or Master's in biomedical engineering or regulatory science with 1-2 years experience
- 1-2 years experience in regulatory operations or software development (preferred)
- Strong attention to detail and ability to follow procedures and processes
- Proficiency in MS Word, Excel, and Outlook with capacity to learn additional software
- Written and oral communication skills and ability to work in fast-paced environments
- Knowledge of data structures, algorithms, and software design fundamentals
- Experience writing technical specifications or user requirements (preferred)
Vacancy posted 6 days ago
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