Full-Time
Regulatory Affairs Specialist
Posted on 10/3/2025
Intuitive Surgical
10,001+ employees
Manufactures robotic surgical systems and services
No salary listed
Sunnyvale, CA, USA
In Person
 Legal & Compliance (2) |
|---|
| , |
- Education: B.S. or higher, preferably in Engineering or in a Science field
- Experience: Minimum 3 years relevant experience working in a medical device company (can be in combination with a regulatory degree; e.g., Masters in Regulatory Science) and/or applicable work for a regulatory agency
- Experience: Minimum 2 years of experience in submissions and technical documentation for medical devices
- Experience: Experience with new product development projects for complex products
- Skills: Ability to create 510(k) submissions, memo-to-files, and technical documentation for complex new products
- Skills: Understanding of design controls with experience in verification and validation methods and documentation
- Skills: Able to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility testing, sterilization
- Skills: Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions
- Skills: Good interpersonal skills and able to work well with cross-functional teams
- Skills: Good project management skills
- Prepare and submit sections of or complete 510(k)s (FDA) to obtain regulatory clearances for new products, new indications, and significant product changes in a timely manner
- Prepare “Memo to File” documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvals
- Support product development teams on regulatory issues, including review of documentation
- Provide insight on documentation issues and guide teams on regulatory requirements
- Support continuous improvement of the submission process in accordance with Intuitive Surgical Product Development Process
- Work indirectly or directly or with regulatory agencies on regulatory issues and submissions
- Support international regulatory efforts as needed
- Perform other duties as required
Intuitive Surgical designs, manufactures, and sells robotic surgical systems and provides related services and accessories for minimally invasive surgery. The core product helps surgeons perform operations with enhanced precision by guiding robotic arms controlled from a console, allowing procedures to be done through small incisions. Instruments and consumables are used with the systems and are supported by service contracts, creating a recurring revenue stream. Compared to competitors, Intuitive has a large installed base and focuses specifically on robotic-assisted surgery, combining devices, disposable instruments, and ongoing services to support hospitals and surgical centers. Its goal is to improve patient outcomes by enabling safer, less invasive procedures while expanding the use and capabilities of robotic surgery for more procedures and providers.
Company Size
10,001+
Company Stage
IPO
Headquarters
Sunnyvale, California
Founded
1995
Simplify's Take
What believers are saying
- da Vinci 5 updates create software-driven upgrades and workflow monetization.
- Ion growth expands a second engine beyond soft-tissue robotic surgery.
- Installed base above 11,000 systems supports durable consumables and service growth.
What critics are saying
- FDA recalls on da Vinci instruments threaten recurring revenue and surgeon trust.
- Lower-cost robotic rivals pressure placements, pricing, and hospital contract renewals.
- MedTech valuation compression can outpace Intuitive's earnings growth for months.
What makes Intuitive Surgical unique
- Pioneer of robotic-assisted surgery, anchored by da Vinci and Ion platforms.
- Global leader in minimally invasive care, serving hospitals and surgical centers.
- Large recurring revenue base from instruments, accessories, and service contracts.
Help us improve and share your feedback! Did you find this helpful?
Your Connections
People at Intuitive Surgical who can refer or advise you
Benefits
Hybrid Work Options
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↑ 0%2 year growth
↑ 0%Intuitive Surgical could emerge as a dark horse in the anti-obesity market as bariatric surgery proves more effective than GLP-1 drugs for long-term weight loss. A recent study of over 50,000 patients found surgery patients lost an average of 58 pounds after two years, compared to just 12 pounds for those using GLP-1 medications. The study also showed surgery delivers more sustainable results. Gastric bypass patients maintain around 52% of their excess weight loss after 10 years, whilst GLP-1 users often regain all lost weight after stopping treatment. Intuitive's da Vinci surgical system offers minimally invasive bariatric surgery options. The company generated $10.1 billion in revenue last year, up from $8.4 billion, with profit margins around 28%. Despite shares falling over 20% this year, the company's position in surgical innovation makes it a compelling long-term investment.
Intuitive Surgical has experienced recent share price weakness, declining 3% in one day with negative returns over the past week, month and three months. The stock currently trades at $452.66, down 10.1% over one month and 19.45% year-to-date, though three-year total shareholder returns remain strong at 77.19%. The medical technology company reports annual revenue of $10.1 billion and net income of $2.9 billion, maintaining a dominant position in minimally invasive surgical technology. According to one valuation analysis, Intuitive Surgical's fair value sits at $532.46, suggesting the stock is undervalued by approximately 15% at current levels. The analysis projects 12% annual revenue growth over the next five years, supported by recurring revenues from spare parts and software licences, with profit margins expected to reach 30% from the current 28.6%.
Intuitive Surgical shares rose 23% following Jim Cramer's recommendation on CNBC's Squawk on the Street in June 2025, where he urged investors to "just go buy ISRG". The medical robotics company experienced a 27% surge in October after reporting third-quarter earnings that beat analyst estimates. Revenue reached $2.51 billion against expectations of $2.40 billion, whilst adjusted earnings per share hit $2.40 versus the predicted $1.98. However, the stock declined 2.7% in January 2026 after Intuitive Surgical released preliminary fourth-quarter results, citing concerns that Medicaid funding cuts and competing products could slow growth of its robotic surgical systems. Despite the recent setback, shares remain up significantly since Cramer's initial endorsement, though they're down 7.8% over the past year.
Intuitive Surgical faces headwinds from tariffs and increased competition in the robotic-assisted surgery market, yet its fundamentals remain strong. The medical device company reported fourth-quarter revenue growth of 19% to $2.87 billion, whilst adjusted earnings per share rose 14.5% to $2.53. Procedures using its da Vinci surgical system increased 17%, with the installed base growing 12% to 11,106 units. However, the stock trades at 47.6 times forward earnings, compared to the healthcare sector average of 17.1. New competition is emerging, with Medtronic's Hugo system recently cleared and Johnson & Johnson expected to launch its own device soon. Despite these challenges, Intuitive Surgical maintains advantages through switching costs and extensive real-world data, whilst the underpenetrated robotic-assisted surgery market offers long-term growth potential.
Intuitive Surgical maintained a 37% operating margin in Q4 despite tariffs creating a 95 basis point drag, alongside higher facility costs and unfavourable product mix from newer platforms like da Vinci 5 and Ion. The company offset these pressures through product cost reductions, component savings and manufacturing efficiencies. Procedure growth of 18% in Q4 and recurring revenue now comprising 81% of total revenues provided operating leverage. Management's 2026 gross margin guidance of 67-68% suggests continued stability, even as tariff headwinds are expected to increase to roughly 1.2% of revenues. Meanwhile, Boston Scientific expanded adjusted operating margins by 100 basis points to 28% in 2025, though tariffs will offset favourable product mix in 2026. The company expects 50-75 basis points operating margin expansion in 2026 through scale efficiencies and supply-chain optimisation.