Regulatory Specialist II

The Fountain Group

Alameda, CA

JOB DETAILS
SALARY
$56–$60 Per Hour
SKILLS
Agile Programming Methodologies, Chinese Language, FDA (Food and Drug Administration), ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Japanese Language, Medical Equipment, Microsoft Office, Microsoft SharePoint, Multilingual, Problem Solving Skills, Product Engineering, Product Management, Record Keeping, Regulations, Status Reports, Time Management
LOCATION
Alameda, CA
POSTED
Today
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.
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.

About the Company

T

The Fountain Group

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/