Regulatory Investigator I: Quality & Compliance

FDA; Maplewood (MO); On-site; USD 65,000 - 80,000; Full time

Job summary

FDA invites applications for Investigator I under streamlined hiring authority. The role involves inspecting FDA-regulated facilities, collecting samples, and evaluating compliance with U.S. laws to prevent unsafe products from reaching patients and consumers.

It requires a degree in QA/related field and 1 year of experience, or an advanced degree, or 3+ years of comparable FDA-regulated experience. The office location is in the U.S.

Qualifications

• Bachelor's degree in quality assurance/management, data science, statistics, computer forensics, epidemiology, pharmacy, public health, engineering, food science, law or regulations, or related healthcare or science field.

Responsibilities

• Conduct inspections of FDA-regulated facilities and products to assess compliance with U.S. laws and regulations.
• Prepare and submit reports with supporting evidence documenting violations of the FD&C Act and related laws.
• Mentor less experienced personnel and provide stakeholder outreach and education.

Skills

Quality assurance

Regulatory compliance

Data analysis

Investigations

Education

Bachelor's degree in QA/management or related field

Master's degree in QA/management or related field

3+ years relevant experience in FDA-regulated environment

Job description

FDA invites applications for Investigator I under streamlined hiring authority. The role involves inspecting FDA-regulated facilities, collecting samples, and evaluating compliance with U.S. laws to prevent unsafe products from reaching patients and consumers.

It requires a degree in QA/related field and 1 year of experience, or an advanced degree, or 3+ years of comparable FDA-regulated experience. The office location is in the U.S.