Regulatory Specialist II

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.