Consumer Safety Officer

Duties

As an Consumer Safety Officer in the Office of In Vitro Diagnostics and Radiological Health (OIR), you will be responsible for:

• Maintaining personal contact with other organizational units within the Center and Agency, and the Regulated Medical Device Industry in order to inculcate the most advanced theories and practices in the medical devices field into the assigned team, Division and/or Office programs;
• Acting as the technical authority involving programmatic operations and activities related to the enforcement of the Medical Device Amendments of 1976 including the Safe Medical Device Act of 1990 and 1992, and/or Radiation Control for Health and Safety Act of 1968;
• Training, assisting, and guiding individuals in the area of safety and effectiveness involving regulated medical devices and/or radiation emitting products;
• Developing and interpreting policy guidance in response to specific requests from the medical device and electronic product industries, trade associations, other Federal agencies, other countries, State agencies, and the general public; and
• Facilitating resolutions of difficult medical devices issues via rigorous scientific inquiry and interactions with internal and external constituents, including industry organizations and other agency components.

Qualifications

**In order to qualify for the Consumer Safety Officer, 0696/14 level, you must meet the following basic requirement (you must submit a copy of your transcripts) AND specialized experience below.

Basic Requirement:**
A bachelor's or higher degree that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming.
OR
Combination of education and experience -- courses consisting of at least 30 semester hours in the fields of study described in A above, plus appropriate experience or additional education. The quality of the combination of education and experience must be sufficient to demonstrate that the applicant possesses the knowledge, skills, and abilities required to perform work in the occupation, and is comparable to that normally acquired through the successful completion of a full 4-year course of study with a major in the appropriate field. In addition to courses in the major and related fields, a typical college degree would have included courses that involved analysis, writing, critical thinking, research, etc. These courses would have provided an applicant with skills and abilities sufficient to perform progressively more responsible work in the occupation. Therefore, creditable experience should have demonstrated similarly appropriate skills or abilities needed to perform the work of the occupation.

Specialized Experience:
You must have at least one full-time year (12-months) of specialized experience equivalent to at least the GS-13 grade level in the Federal service that included:

• Negotiating with the medical device and/or radiological health industry for acceptance of recommendations and requirements which involve changes in established processes and activities, and conflict with the desires or goals of the medical industry;
• Identifying and working to resolve critical health issues that involve scientific and regulatory aspects related to the implications and impacts from the use of unsafe and dangerous consumer products; and
• Interpreting and implementing regulations, procedures, and policies of compliance organizations and programs in the medical device and/or radiological health area of unapproved and misbranded medical devices.

(This experience must be clearly demonstrated in your resume).

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE MAY NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. If your resume does not support your questionnaire answers, we will not allow credit for your response(s).

NOTE: Experience refers to paid and unpaid experience, including volunteer work done through national Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to gain employment. You will receive credit for all qualifying experience, including volunteer experience. If such experience is on a part-time basis, you must provide the average number of hours worked per week as well as the beginning and ending dates of the experience so it can be fully credited.

Education

If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education.