Position is for 1 year with the possibility of extensions.
Onsite only in Alameda CA.
Manager is looking for:
Education: Bachelors 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.
¿ Strict to work 40hrs per week.