Regulatory Specialist II at The Fountain Group

The Fountain Group is a national staffing firm and we are currently seeking a Regulatory Specialist  for a prominent client of ours.  This position is located in Alameda, CA (onsite) 

Details:

• THIS POSITION IS 100% ONSITE
• Pay for this position is 56.00 to 60.00 hourly depending on experience
• This position is a one year contract with the possibility of extension or conversion to permanent.

Required:

• 5+ years of regulatory affairs experience
• Medical Device regulatory affairs experience

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.

Other Preferred (not required) Experience:

• Bilingual (Japanese or Chinese)
• 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.