Regulatory Specialist II (APAC/Regulatory Submissions)
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Job Description
Education: Bachelor s degree
Experience Background (Any): APAC regulatory submissions in Medical Devices or Pharmaceutical industries.
Job Description (Expectation):
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.
Other:
Knowledge of International Standards, such as ISO13485, IEC60601.
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.