Senior Regulatory Specialist

Job Description:

Pay Range: $55.49hr - $60.49hr

Responsibilities: 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. ble to start projects immediately after internal system training. Other 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. bility to manage time and projects. Bachelor's degree Experience Background. PAC regulatory submissions in Medical Devices or Pharmaceutical industries.