This is primarily an investigator position, and for inspection work, the incumbent will receive inspectional/investigational assignments and technical supervision directly from the Office of Regulatory Affairs (ORA) Headquarters following established procedures (with the exception of those selected for positions in Shanghai, Guangzhou, or India post may receive assignments from a Supervisory Consumer Safety Officer).
As Consumer Safety Officer, you will:
- Serve as an Assistant Country/Regional Director in foreign investigation/inspection assignments (primarily foods, feed, medical devices, clinical trials/research, drugs or biologics) in one of FDA Foreign Post locations.
- Serve as the focal point within FDA to whom headquarters and field service may turn for authoritative guidance and consultation regarding inspectional and investigational methods and procedures necessary to accomplish compliance objectives in their major functional area and country of assignment.
- Make recommendations that may affect the status or decision of the Agency as to the status of domestic or foreign products or to permit the entry of the inspected product.
- Provide a focal point within FDA to whom foreign manufacturers may turn to for regarding inspectional activities and how to comply with GMPs or other regulatory requirements and investigation methods and procedures necessary to accomplish compliance objectives.
- Regarding technical and scientific matters, inspectional/investigational issues, policies, and laws for industry representatives, foreign governments and local officials.
- Conduct on-the-job
and other training for investigators, supervisors, compliance officers, district or regional personnel, and other FDA personnel regarding technical and scientific matters, inspectional/investigational issues, policies and laws.
- Gather information on the regulated industry, preventive controls and industry practice in their major functional area and country of assignments.
- Serve as an operational focal point to facilitate the establishment of an auditing and certification program within the host country.
- Work directly with the local or foreign national government to communicate standards and conduct public health systems evaluations.
- Conduct audits that consist of follow-up inspections, and systems audits designed to evaluate the effectiveness of the foreign government's regulatory oversight process and of public and private sector certification processes for helping ensure that exported products meet FDA standards .