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1. From the descriptions below, select the one which best describes your experience which meets the Minimum Qualification Requirements for Policy Advisor, GS-0301-14.A. I have one year of specialized experience, equivalent to the GS-13 grade level in the Federal service, providing advice on the development of regulatory and/or enforcement policy concerning FDA laws and regulations.
For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Darken the oval corresponding to that statement in Section 25 of the Qualifications and Availability Form C. Please select only one letter for each item.A- I have not had education, training or experience in performing this task.
2. Interprets and applies legislation, including recently passed device-related provisions of Food and Drug Administration Safety and Innovation Act (FDASIA).
3. Develops, revises, or reviews policy documents, such as regulations, guidance documents, and reports related to legal and regulatory policies.
4. Recommend changes to policies and procedures to ensure timely issuance of appropriate compliance and guidance documents.
5. Advises organization staff by applying knowledge of the Federal Food, Drug and Cosmetic act, and other pertinent laws and regulations, in development, review and evaluation for documents related to medical devices to identify areas of concern and determine conformance with these laws.
6. Assists other organizations in determining, whether concepts for regulations, guidance documents, and other information disseminations raise legal or policy concerns and provides counsel for addressing those concerns.
7. Provide legal guidance to an organization on emerging public health concerns and other sensitive issues.
8. Represents an organization in meetings and conference with various stakeholders.
9. Attends and participates with industry and trade groups in the presentation of legal groups in the presentation of legal and regulatory requirements.
10. Meets with other organizations in industry to discuss resolution of regulatory issues.
11. Participates in briefings of Congressional members and staff.
12. Develops, writes, and reviews high quality reports and other policy documents intended for consumption by multiple stakeholders, high-level administration agency and administration officials, and legislators.
13. Analyze quality techniques and best practice models to resolve a program's customer service issues.
14. Develop indicators to provide objective evidence of the effectiveness of quality procedures and controls within a program area.