Responsibilities :
- Responsible for regulatory activities, including product registrations, regulatory 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.
- Able to start projects immediately after internal system training.
Requirements :
- Knowledge of International Standards, such as ISO, IEC.
- Knowledge of interactions between RA and other departments to pre / post-market RA activities.
- 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.
- Able to manage time and projects.
- Able to complete the tasks with minimum supervision.
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