Regulatory Operations Specialist (Medical Devices)

Regulatory Jobs; Sunnyvale (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Intuitive Surgical in Sunnyvale, CA, is seeking a regulatory operations professional to provide regulatory and operational support for new country product launches, site registrations, and site renewals, plus preparation of standardized technical documentation for global submissions. You will collaborate with development teams and cross‑functional partners to improve regulatory tools and workflows.

The role emphasizes process improvement, drafting procedures and templates, and supporting audits.

Qualifications

• 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.

Responsibilities

• 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

Skills

Data structures and algorithms

Software design

Attention to detail

Communication skills

Multi-tasking

Team player

MS Word

MS Excel

MS Outlook

Problem solving

Education

Bachelor's degree in science or related field

Master's degree in Biomedical Engineering or Regulatory Science

Tools

MS Word

Excel

Outlook

Job description

Intuitive Surgical in Sunnyvale, CA, is seeking a regulatory operations professional to provide regulatory and operational support for new country product launches, site registrations, and site renewals, plus preparation of standardized technical documentation for global submissions. You will collaborate with development teams and cross‑functional partners to improve regulatory tools and workflows.

The role emphasizes process improvement, drafting procedures and templates, and supporting audits.