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Regulatory Affairs Specialist 3 - Job Opportunity at Intuitive Surgical

Sunnyvale, United States
Full-time
Senior
Posted: March 26, 2025
On-site
USD 97,600 - 165,200 per year

Benefits

Competitive base salary with regional adjustments
Equity compensation package
Healthcare benefits package
Incentive programs

Key Responsibilities

Lead regulatory strategy for Class II medical device submissions and technical documentation
Drive compliance through cross-functional team guidance and documentation review
Manage FDA 510(k) submissions for new products and modifications
Direct international regulatory compliance efforts
Facilitate regulatory agency interactions and inspections
Support continuous improvement of submission processes

Requirements

Education

B.S. or higher in Engineering or Science field

Experience

Minimum 2 years in regulatory affairs for Class II medical devices and 3 years in medical device industry

Required Skills

510(k) submission expertise Design control understanding Technical documentation management Cross-functional team collaboration Project management Verification and validation methods Third-party test requirement knowledge Excellent verbal and written communication
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Sauge AI Market Intelligence

Industry Trends

The medical device regulatory landscape is experiencing increased scrutiny, particularly in software and AI integration, creating high demand for specialists who can navigate complex submission requirements. Global harmonization efforts like EU MDR and IVDR are driving need for regulatory professionals with international expertise. Remote healthcare technology acceleration is creating new regulatory challenges and opportunities in the surgical robotics space.

Salary Evaluation

The offered salary range is competitive for the Silicon Valley market, with potential for growth based on experience and regional adjustments. Senior regulatory specialists in medical devices typically command $120,000-180,000 in this region.

Role Significance

Typically part of a 5-10 person regulatory affairs team, collaborating with 20-30 cross-functional team members
Senior individual contributor role with significant influence on product development and market access strategies

Key Projects

New product submissions for surgical robotics systems Platform technology modifications and updates International market expansion initiatives Regulatory strategy development for emerging technologies

Success Factors

Deep understanding of FDA and international regulatory frameworks Ability to balance compliance requirements with business objectives Strong project management skills with multiple concurrent submissions Excellent stakeholder management across R&D, Quality, and Clinical teams

Market Demand

Very high demand due to increasing regulatory complexity in medical devices and limited talent pool with specific Class II device experience

Important Skills

Critical Skills

510(k) submission expertise - Essential for product commercialization Technical documentation management - Core to regulatory compliance Cross-functional collaboration - Critical for successful submissions

Beneficial Skills

International regulatory knowledge Quality system expertise Clinical evaluation experience Risk management proficiency

Unique Aspects

Opportunity to work on cutting-edge surgical robotics technology
Direct impact on global healthcare delivery through regulatory strategy
Complex technical environment requiring broad regulatory expertise
High visibility role with significant cross-functional exposure

Career Growth

Typical progression to management role in 2-4 years with demonstrated success in complex submissions

Potential Next Roles

Regulatory Affairs Manager Senior Manager Global Regulatory Affairs Director of Regulatory Affairs Head of Regulatory Strategy

Company Overview

Intuitive Surgical

Intuitive Surgical is the global leader in robotic-assisted minimally invasive surgery, pioneering advanced technology in healthcare

Dominant market position in surgical robotics with significant growth trajectory and continuous innovation pipeline
Silicon Valley headquarters with global operations and strong presence in major medical device markets
Innovation-driven environment with high emphasis on quality and compliance, balanced with strong engineering culture
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