Regulatory Affairs Specialist - The Fountain Group
St. Louis, MO
About the Job
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:
Shift Details:
- Monday-Friday 9AM-5PM
- Hybrid role- Manager is looking for someone to come onsite 2-3 days a week.
- 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.
- 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.)
Source : The Fountain Group