Location
Sunnyvale, CA, United States
Posted
July 23, 2026
Job Description
Job Title: Regulatory Affairs Specialist IV
Location: Sunnyvale, California
Type: 6 month contract
Compensation: $55-60/hour depending on qualifications
Work Model: Hybrid – 3 days onsite
Hours: 40.0
Overview
Lead regulatory strategy and submissions for medical devices, supporting product development, design changes, lifecycle management, and regulatory approvals across the U.S., Canada, and global markets.
Responsibilities
• Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
• Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets. Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes. Influence and lead global regulatory strategies.
• Author and lead regulatory documentation and submissions, including U.S. FDA 510(k) premarket notifications, intern...
Location: Sunnyvale, California
Type: 6 month contract
Compensation: $55-60/hour depending on qualifications
Work Model: Hybrid – 3 days onsite
Hours: 40.0
Overview
Lead regulatory strategy and submissions for medical devices, supporting product development, design changes, lifecycle management, and regulatory approvals across the U.S., Canada, and global markets.
Responsibilities
• Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
• Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets. Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes. Influence and lead global regulatory strategies.
• Author and lead regulatory documentation and submissions, including U.S. FDA 510(k) premarket notifications, intern...