Regulatory Affairs Technical Lead

Intuitive•Sunnyvale, CA

2d•$154,700 - $262,000•Onsite

About The Position

The Regulatory Affairs Technical Lead leads regulatory initiatives for enterprise-wide products or platforms, drives regulatory strategy, and collaborates with executive and cross-functional teams to support compliance and market expansion. The role develops global regulatory strategies for complex product portfolios; leads regulatory strategy, submissions, and agency communications for the United States and Canada; and coordinates with outside-the-U.S. regulatory teams on product registrations and variations. It also advises executives and teams on regulatory risks, trends, and compliance options; responds to major agency inquiries, inspections, and audits; tracks regulatory changes and their business impact; and provides metrics, dashboards, and executive communications on regulatory efforts. The position develops training materials, reviews and updates project documentation, mentors regulatory team members, and represents the company in industry and regulatory forums. The role requires 10–12 years of regulatory affairs experience and a bachelor’s degree in a relevant discipline, or an equivalent combination of education and experience. It calls for mastery of global regulatory affairs, strategy, and submissions; executive-level communication and negotiation skills; leadership and mentorship ability; advanced technical writing, analytics, and project management; and experience working across functions and with agencies worldwide. Experience with ML/CADe/x validation and global regulatory requirements, and gaining FDA clearances for ML, CADe/x, and complex medical devices, is also required. The position is scheduled as a day shift and is onsite weekly, with the percentage of onsite work determined by the leader. Intuitive may require current proof of vaccination against certain diseases, including COVID-19, depending on the role. The position may be filled at a different job level based on business needs and the selected candidate’s experience, knowledge, and skills. Compensation is based on job level and qualifications; target salary ranges are provided for two regions.

Requirements

10–12 years of experience in regulatory affairs and a bachelor’s degree in a relevant discipline, or an equivalent combination of education and experience.
Mastery of global regulatory affairs, regulatory strategy, and submission expertise.
Executive-level communication and negotiation skills.
Strong leadership and mentorship skills for regulatory teams.
Advanced technical writing, analytics, and project management skills.
Track record of collaborating across functions and with agencies worldwide.
Experience with ML/CADe/x validation and global regulatory requirements.
Experience gaining FDA clearances for ML, CADe/x, and complex medical devices.

Responsibilities

Develop global regulatory strategies for complex product portfolios.
Advise executives and teams on regulatory risks, trends, and compliance options.
Lead complex regulatory strategy, submissions, and agency communications for the United States and Canada.
Lead responses to major regulatory agency inquiries, inspections, and audits.
Develop training materials on new regulations and regulatory changes.
Review, approve, and update project documentation.
Track and analyze global regulatory changes and their impact on the business.
Mentor regulatory team members.
Coordinate with outside-the-U.S. global regulatory teams on product registrations and variations.
Provide metrics, dashboards, and executive communication on regulatory efforts.
Represent the company in industry and regulatory forums.