Job Overview

Summary

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.

This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Global Regulatory Operations and Policy (OGROP), in the Office of International Programs (OIP), FDA Foreign posts. This position has 7 different locations: New Delhi, India; Mumbai, India; Mexico City, Mexico; Shanghai, China; Beijing, China, Hyderabad, India and Guangzhou, China.
Who May Apply:  Open to all United States Citizens.
This announcement may be used to fill multiple positions in multiple locations.

Overseas Assignments: Overseas assignments are for two years and a rotational agreement must be signed. The assignment may be extended up to a total of four years based on the needs of the agency. Subsequent employment for other FDA positions must be through the appropriate competitive process or special employment program hiring authorities.

Immunizations are required and will be administered by the FDA before relocating overseas, when applicable.

Before relocating overseas, the selectee may remain stateside until all clearances have been approved.

Employment is contingent on passing required medical and security clearances.

Security clearances are required for the selectee only and medical clearances are required for selectee and all family members before being posted overseas.   Inability of selectee to secure the clearances for overseas duty within six (6) months will result in termination of appointment to the position.

Citizens or permanent residents of the host country are not eligible to be considered.

Additional information on living and traveling abroad may be found at

http://aoprals.state.gov/content.asp?content%20id=184&menu%20id=78.

Special Notes:

Although this vacancy announcement is advertised for multiple duty locations, and grade levels, it is not intended to convey any implication nor expectation that positions will be filled at all grade levels or locations. Based upon the position responsibilities and/or Department of Health and Human Services hiring office, the full performance level of the positions may vary.

This announcement is being used to create an inventory of applicants for Consumer Safety Officer positions and will be used to fill immediate and future needs. Applicants are encouraged to apply early in order to maximize their employment opportunities. Your application will remain in the inventory of tentatively qualified applicants. Applicants that are among the best qualified will be referred to the selecting official for consideration as requests to fill vacancies are processed by the Human Resources Center. Thereafter, additional referral lists will be generated throughout the open period as vacancies occur. If further evaluation or interviews are required, you will be contacted.

This position is eligible for special pay allowances (e.g. post differential, cost of living, housing, relocation expenses, etc.). Reference the Department of State, Office of Allowances at http://aoprais.state.gov.
Immunizations are required and will be administered by the FDA before relocating overseas, when applicable.

Before relocating overseas, the selectee may remain stateside until all clearances have been approved.

Employment is contingent on passing required medical and security clearances.

Security clearances are required for the selectee only and medical clearances are required for selectee and all family members before being posted overseas. Inability of selectee to secure the clearances for overseas duty within six (6) months will result in termination of appointment to the position.

Citizens or permanent residents of the host country are not eligible to be considered.

Current permanent status FDA employees will be processed using the appropriate temporary promotion or other temporary assignment authority for permanent employees FDA. The selectee will have statutory return rights to their permanent FDA position title, series, and grade once the overseas assignment is completed.

Other current permanent status Federal employees will be hired on a term appointment. There are not statutory return rights. Subsequent employment for FDA positions must be through the appropriate competitive process or special employment program hiring authorities.

All other selectees (e.g., reinstatement eligibles, veterans, persons with disabilities, etc.) will be hired through a term-appointment. Subsequent employment of FDA positions must be through the appropriate competitive process or special employment program hiring authorities.

Additional information on living and traveling abroad may be found at http://aoprais.state.gov/default.asp

Initial cutoff will be 2 weeks from the announcement's opening date.

Duties

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, who will receive assignments from a Supervisory Consumer Safety Officer).

If selected for this position you will:

- Serve as an Assistant Country/Regional Director in foreign investigation/inspection assignments (primarily foods, feeds, medical devices, clinical trials/research, drugs or biologics) in one of FDA Foreign Post.

- 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/region 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 for technical expertise regarding inspectional activities and how to comply with GMPs or other regulatory requirements and investigation methods and procedures necessary to accomplish compliance objectives.

- Develop and implement formal training programs 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/region of assignment .

- 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.

  • Additional Duty Location Info

    Many vacancies in the following locations

    • Guangzhou China
    • New Delhi India
    • Beijing China
    • Mumbai India
    • Shanghai China
    • Mexico City Mexico
    • Hyderabad India