Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)

Regulatory Affairs Manager

The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances.

Key responsibilities include:

• Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies.
• Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
• Provide regulatory support to product development teams by offering guidance on applicable regulations and documentation requirements.
• Stay current on changes in regulatory requirements and assist in assessing the impact on company processes and products.
• Perform regulatory assessments for product changes and propose appropriate regulatory pathways.
• Maintain documentation and records of all regulatory submissions and correspondence.
• Support the preparation for regulatory agency meetings, audits, and inspections.
• Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory deliverables are met in a timely manner.