Regulatory Specialist II
The Fountain Group
The Fountain Group is a national staffing firm and we are currently seeking a Regulatory Specialist for a prominent clientof 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.
- 5+ years of regulatory affairs experience
- Medical Device regulatory affairs experience
- 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.
- 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.
Vacancy posted 3 days ago
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