Regulatory Affairs Technical Lead

Intuitive • Sunnyvale, CA

1d

About The Position

The Regulatory Affairs Technical Lead leads regulatory initiatives for enterprise-wide products or platforms, develops regulatory strategy, and collaborates with executive and cross-functional teams to support compliance and market expansion. The role covers complex global product portfolios, with responsibility for regulatory strategy, submissions, agency communications, and regulatory change management. It also provides leadership and mentorship to regulatory team members and executive-level updates on regulatory efforts.

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 US 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 OUS 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.

Benefits

• Market-competitive compensation packages, including base pay, incentives, benefits, and equity.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior