Job: Regulatory Assistant

Title Regulatory Assistant
Categories Regulatory
Job Information

GENERAL DESCRIPTION

Assist the Regulatory Affairs Department in the following areas:

  • Perform regulatory research and assist in implementing/maintaining a regulatory filing system;
  • Draft, implement and maintain FDA Food Safety Modernization Act (FSMA) systems;
  • Draft, implement and maintain a USDA FSIS approved HACCP (Hazard Analysis and Critical Control Point) systems;
  • Maintain working relationship with local USDA officials;
  • Assist with responses and corrective actions to USDA FSIS NRs (Noncompliance Reports);
  • Draft responses and assist sales with customer regulatory inquiries/concerns;
  • Draft and maintain processing procedures and flow diagrams;
  • Draft and maintain distributor letters for API (Active Pharmaceutical Ingredient) customers;
  • review SDS (Safety Data Sheet) drafts;
  • assist in drafting and maintaining Certificates of Suitability;
  • Further responsibilities and duties as deemed necessary.

WORK EXPERIENCE REQUIREMENTS

  • Knowledge/experience with 9 CFR 300-500 USDA FSIS regulations.
  • Knowledge/experience in a US-FDA Q7A environment with associated cGMP (current Good Manufacturing Practices) work requirements.
  • Knowledge/experience in 21 CFR 110 and/or 21 CFR 117.

EDUCATION REQUIREMENTS

  • Bachelor’s degree and/or a minimum of 5 years of work experience with FDA and/or USDA FSIS regulations.
  • Working knowledge or experience with computer word processing, spreadsheet, database, and/or flow charting programs.

 

 

Apply Now