Global Medical Device Regulatory Ops Specialist

Intuitive; Sunnyvale (CA); On-site; USD 89,000 - 105,000; Full time

Job summary

Intuitive Surgical is seeking a Regulatory Operations Specialist to provide regulatory and operational support for global product launches and site registrations. You will draft standardized technical documentation, assist with facility transfers, and collaborate with cross-functional teams to improve regulatory tools and processes.

The role requires 0–2 years in medical devices, strong attention to detail, and proficiency in MS Word/Excel/Outlook, with opportunities to grow in regulatory

Qualifications

• Minimum 0-2 years relevant experience in a medical device company.
• 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

Responsibilities

• Provide regulatory and operational support for new country product launches and global site registrations.
• Prepare Standardized Technical Documentation for medical devices for global submissions
• Assist with facility transfers and manufacturing line transfer projects
• Draft and update regulatory procedures and work tools to promote efficiency
• Review procedures and identify process improvements based on data and user experience
• Collaborate with development teams to design tools and applications for regulatory workflows
• Support audit team in preparing documents for audits

Skills

Regulatory operations

Technical documentation

Attention to detail

Communication skills

MS Office

Education

Bachelor's degree in science

Master's degree or foreign equivalent

Tools

MS Word

Excel

Outlook

Job description

Intuitive Surgical is seeking a Regulatory Operations Specialist to provide regulatory and operational support for global product launches and site registrations. You will draft standardized technical documentation, assist with facility transfers, and collaborate with cross-functional teams to improve regulatory tools and processes.

The role requires 0–2 years in medical devices, strong attention to detail, and proficiency in MS Word/Excel/Outlook, with opportunities to grow in regulatory