Company Profile
FDA Office of Regulatory Affairs
Company Overview
FDA Office of Regulatory Affairs (ORA)
The Office of Regulatory Affairs, which includes virtually all the field offices of FDA as well as a significant presence in the Washington DC Metropolitan area, serves as the traditional eyes and ears of the agency through its network of investigators and laboratory analysts. ORA works closely with each of the FDA Centers and with other components of the agency to enforce the laws that protect and advance the public health. ORA protects consumers by maximizing compliance of FDA-regulated products and minimizing risk associated with those products. More than 5,000 ORA professionals work in a range of program areas and locations in 227 offices and 13 laboratories throughout the United States every day to maximize compliance of regulated products and to minimize public health risk. ORA regulates more than 135,000 business establishments that annually produce, warehouse, import, and transport $1 trillion worth of consumer goods.
Company History
Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
Join FDA and serve on the front lines protecting our nation's public health safety within the Office of Regulatory Affairs (ORA). At ORA, we work in a range of program areas and locations, with 227 offices and 13 laboratories throughout the nation or around the world. Our employees inspect product facilities; investigate criminal violations; analyze lab samples; provide administrative services, and much more. Be a part of ensuring that the thousands of products we use every day are safe and effective.
Winchester Engineering and Analytical Center
Welcome to FDA's ORA Winchester Engineering and Analytical Center (WEAC), located just north of Boston in Winchester, MA. The WEAC laboratory provides specialized analytical services in engineering and medical devices and is FDA's only field lab providing radionuclide analyses. The work at the WEAC facility involves comprehensive evaluation of medical devices and radiation emitting appliances. WEAC is the primary field laboratory upon which CDRH relies for analytical services. All engineering analyses for the GWQAP analytical program are performed at WEAC. In addition to the specialized analytical procedures for radionuclides in foods and radiopharmaceuticals, WEAC performs chemical and microbiological testing.
WEAC Mission
The Winchester Engineering and Analytical Center (WEAC) is a team of highly motivated professional scientists, engineers, and associated staff dedicated to protect the public health through efficient, high quality regulatory analyses, research, inspections, and product standards activities. The focus of these efforts are the engineering, biological, and chemical hazards associated with medical devices, electronic products, radionuclides, and radiopharmaceuticals. The results of WEAC's activities play an integral part in FDA's mission to prevent or limit exposure of the public to unsafe or ineffective devices, drugs, and foods.
To view our ORA Vision, Mission, and Values please visit:
https://www.fda.gov/about-fda/office-regulatory-affairs/ora-vision-mission-and-values
Notable Clients
PUBLIC SECTOR
Benefits
TELEWORK
FLEXIBLE WORK SCHEDULES