Regulatory Specialist (Bilingual Japanese or Chinese)

Duties:

Responsible for implementing and maintaining the effectiveness of the quality system.

Supports manufacturing/operations day to day activities for change control.

Provides consultation/advice to regulatory specialist for change control and product development.

Provides regulatory direction/interpretation on team activities.

Interprets and applies regulatory understanding to support of products and teams.

Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.

Handles regulatory activities involved in documentation, labeling, field support.

Applies regulatory and technical knowledge to a wide variety of complex work assignments.

Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.

Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

Responsible for regulatory activities, including product registrations, impact assessment, etc.

Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.

Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.

Plan and execute the given tasks proactively in a timely manner.

Report the status to a manager weekly.

Keep the training records up to date to do the tasks.

Knowledge of International Standards, such as ISO13485, IEC60601.

Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.

Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency.

Ability to manage time and projects.

Skills:

Knowledge of regulations and standards affecting IVDs and/or biologics

Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.