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.  

Who May Apply:  Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Program (ICTAP); veterans who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; Military Spouses; PHS Commissioned Corps Officers; individuals eligible for VRA appointments (at the GS-11 and below grade levels); and individuals with disabilities.

 

This position is located in the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Office of Global Regulatory Operations and Policy (GROP), in the Office of International Programs (OIP), FDA foreign post location.  This position has 8 different locations: New Delhi, India; Mumbai, India; Mexico City, Mexico; Santiago, Chile; Shanghai, China; Beijing, China, Hyderabad, India or Guangzhou, China.

  This announcement will be used to fill multiple positions in various geographical locations.

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-DE-13-789710 under competitive procedures.  Please review that announcement to see if you are eligible for consideration under competitive procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.

 

This position is Full-Time - Temporary Promotion, Temporary Reassignment or Term.

Overseas Assignments:  Overseas assignments are for two years and a rotational agreement must be signed.  The assignment may be extended based on the needs of the agency. Upon completion of the overseas assignment, FDA employees on temporary promotion/assignment will be placed in accordance with FDA placement procedures.   Subsequent employment for other FDA positions must be through the appropriate competitive process or special employment program hiring authorities.

  · This position is eligible for special pay allowances (e.g., post differential, cost of living, housing, relocation expenses, etc.).  Refer to Department of State, Office of Allowances at http://aoprals.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.  

   · 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.  Returning to the last position before foreign posting is not guaranteed.  However, Investigators selected from ORA staff have the option of returning to their original stateside duty station at the conclusion of their rotational assignment.

   · Other current permanent status Federal employees will be hired on a term appointment.  There are no 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 eligible, veterans, persons with disabilities, etc.) will be hired through a term-appointment.  Subsequent employment for 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://aoprals.state.gov/content.asp?content  

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

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, 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 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.

 

- 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 .


  • Additional Duty Location Info

    Many vacancies in the following locations

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