Sonio

Compliance

• Monitor and ensure the timely preparation and tracking of technical documentation related to design changes, in coordination with the relevant teams.
• Assist in documentation preparation and publishing for regulatory submissions.
• Assist in implementing an automated system for the regulatory and standards watch process.
• Proactively monitor and ensure timely renewal of licenses, including Small Business Determination, Device Listing, and Establishment License for the US market.
• Facilitate promotional marketing review by setting up a centralized database of validated marketing and clinical claims.
• Perform regulatory watch to ensure compliance with FDA regulations, ISO standards, and other relevant regulatory requirements, and provide support for regulatory impact analyses.
• Provide support for post-market compliance activities.

Regulatory Affairs Internship