Job Description

Regulatory Affairs Associate

On-site in Santa Clara, CA

12 month contract

Must be able to work on a W2

Job Summary

The Regulatory Affairs Associate will support international regulatory compliance by monitoring changing regulations, ensuring implementation of new requirements, and maintaining quality system processes. This role will manage international submissions, track declarations of conformity, and drive quality system improvements. Responsibilities include coordinating with global teams, troubleshooting regulatory issues, and ensuring compliance with change control and quality requirements. Candidates must have experience in change control, change orders, and quality systems.

Job Responsibilities

• Monitor and interpret international regulatory changes, ensuring compliance within the quality system.
• Manage regulatory submissions, product registration renewals, and declarations of conformity.
• Maintain and update quality system procedures, including change management processes.
• Liaise with internal teams, distribution centers, and international affiliates to align regulatory requirements.
• Support CAPA investigations, implement mitigations, and troubleshoot regulatory issues.
• Maintain regulatory trackers, SharePoint files, and process documentation.

Job Qualifications

• Bachelor's degree in a scientific or regulatory discipline.
• 2+ years of experience in regulatory affairs, quality systems, or compliance within the medical device industry.
• Strong knowledge of change control, change orders, and regulatory quality requirements.
• Experience managing regulatory submissions and tracking compliance documentation.

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