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.
• 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.

Last updated : 2024-04-27