Title: Regulatory Specialist II
Duration: 1 year with the possibility of extension
Location: Alameda CA 94502
Experience Background (Any): APAC regulatory submissions in Medical Devices or Pharmaceutical industries.
Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a
quality, product-development/support, or scientific affairs function Skills: Knowledge of regulations and standards affecting IVDs and/or biologics.
Education: Bachelors degree
Job Description:

• 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.
• Responsible for implementing and maintaining the effectiveness of the quality system.
• Supports manufacturing/operations day to day activities for change control.
• Provides consultation/advice to regulatory specialist for change control and product development.
• Provides regulatory direction/interpretation on team activities.
• Interprets and applies regulatory understanding to support of products and teams.
• Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation,labeling,field support.
• Applies regulatory and technical knowledge to a wide variety of complex work assignments.
• Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
• Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
• 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.

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