Regulatory Affairs Specialist

The Fountain Group

Saint Louis, MO

JOB DETAILS
SALARY
$31.34–$33.57 Per Hour
SKILLS
Budgeting, Code of Federal Regulations, Documentation, FDA Requirements, File Maintenance, ISO (International Organization for Standardization), Maintain Compliance, Medical Equipment, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Regulations, Regulatory Compliance, Reporting Skills, Technical Writing, Time Management, Writing Skills
LOCATION
Saint Louis, MO
POSTED
1 day ago

Currently seeking a Regulatory Affairs Specialist for a prominent client of ours. This position is located in St. Louis, MO. Details for the position are as follows:
Shift Details:

  • Monday-Friday 9AM-5PM
    • Hybrid role- Manager is looking for someone to come onsite 2-3 days a week.
Job Description:
  • Pay: $31.34-$33.57/hr depending on experience.
  • This is a temporary assignment that is slated for 2 years with possibility for extension or conversion based on performance and budget.
  • Position is responsible for independently assemble and maintain technical files and other regulatory documentation to ensure timely registrations and renewals
  • Position is also responsible for assisting and advise in activities related to regulatory registrations, listing, and regulatory compliance, with particular focus on In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR; maintaining compliance with requirements of FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, and other applicable International Medical Device Regulations.
Qualifications:
  • Bachelor's degree or master's degree with 1+ year of experience working within regulatory affairs.
  • Experince with IVD preferred.
  • Knowledge of market, competitors, and authority landscape.
  • Technical and report writing skills.
  • Experince with Microsoft Office Suit (Word, Excel, PowerPoint, Etc.)

About the Company

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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/