Location
Alameda, CA | United States
Job description
Role: Regulatory Specialist II
Location: Alameda, CA - 94502
Duration : 12 Months
Job Description
- 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.
- Strict to work 40hrs per week.
Job tags
Salary
