13 days old
  • Job Type
    Employee
  • Job Status
    Full Time

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.

The Development Coordinator proactively provides advice and counsel to the Associate Director for Advanced Medical Products Manufacturing (AMPM) and other Agency leaders on advanced manufacturing training needs and activities to ensure regulatory training keeps pace with industry advancements. Additionally, the Development Coordinator:
• Engages with external stakeholders (industry, academia, foreign regulatory agencies, etc.) to keep abreast of emerging medical product technologies, advanced manufacturing processes and innovative control and testing strategies and novel platform technologies
• Serves as contracting officer’s technical representative on administrative contracts and task orders. Develops supporting documentation such as financial data, statements of work and schedules of deliverables; monitors contractor performance; and resolves problems. Establishes and maintains tracking systems and records for grant and contract activities in the program.
• Assists OMPTO Programs with developing requirements and expectations for advanced manufacturing contracts.
• Develops an annual training plan for OMPTO, based on an assessment of past training, surveys, and input from the various organizational elements and Headquarters with the goal of training as many personnel within allocated resources.
• Manages the development or implementation of technical and programmatic training at the OMPTO level as required to meet the identified needs.
• Serves as a training officer for courses or material purchased or developed through vendors and contractors and serves as FDA liaison for courses or materials developed through interagency agreements.
• Interprets and communicates existing policies to satisfy new circumstances based upon FDA goals.
• Develops or reviews of training/course materials, aids, devices, etc., and evaluation of training results.
• Works in the occupation or subject-matter field of the position to be filled that required training or instructing others on a regular basis.
Conditions

Requirements

To be placed into a Cures position, candidates must meet the following criteria:
1. Scientific, Technical, and Professional Fields
2. Qualified and Outstanding Candidates
a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline
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for comparing experience levels and other candidate attributes for relevant positions. b. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.
In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.
Education Requirement: The education must have been obtained at a college, university, or an
accrediting body recognized by the Secretary, U.S. Department of Education at the time the
degree was obtained. For more information please see: OPM Occupational Series Qualification Requirements
Consumer Safety Officer Series, 0696
Professional Experience:
• Knowledge of the principles, theories and practices related to advanced manufacturing including regulatory.
• Knowledge of the principles, theories, and practices of related scientific or professional fields that enable the incumbent to carryout tasks related to regulatory activities in medical devices and radiological health products.
• Knowledge of inspectional and investigative techniques associated with the regulation of the domestic and international industries within the medical products device and radiological health and advanced manufacturing technologies functional program area.
• Comprehensive knowledge of the FD&C Act and regulations, related acts, laws legislation and precedents, that govern the procedures and guidance materials of ORA and associated organizations.
• Thorough knowledge of the principles and practices of manufacturing technologies in medical devices and radiological products health to serve as a technical authority on current and emerging technologies to provide authoritative advice and assistance to other senior technical experts on extensive and complicated manufacturing processes and operations and training opportunities.
• Knowledge of legislation, laws, precedents, and regulations which govern ORA’s activities related to Medical Device and Radiological Health Products to serve as a technical authority to interpret and provide advice on all related policies and develop new or revised existing approaches, precedents, and methods.
• Skill in oral and written communications to make clear, convincing presentations; represent the Agency at meetings and conferences; interact with high level officials and representatives from public and private public health organizations.
• Knowledge of a wide range of advanced manufacturing and emerging product technologies and qualitative and quantitative analytical methods and techniques to provide the Office Program Directors, ACMPTO and other senior staff of ORA with
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authoritative information, analyses, advice, and assistance in the formulation and solution of major, complex, and sensitive issues, emerging technology and problems which face ORA.

Categories

Posted: 2022-11-14 Expires: 2022-12-14

FDA’s Office of Regulatory Affairs (ORA) is the lead office for all agency regulatory activities. Over 5,000 ORA employees strategically located in district offices, resident posts, and laboratories throughout the United States perform inspections and investigations (including criminal investigations), wharf exams, sample collections and analyses, and carry out enforcement activities, education, and outreach directly to consumers, industry representatives, importers, and shippers as well as other stakeholders across the nation. ORA also works with its federal, state, local, tribal, territorial, and foreign counterparts to further the agency’s mission. ORA is led by the Associate Commissioner for Regulatory Affairs (ACRA).

To view our ORA Vision, Mission, and Values please visit: https://www.fda.gov/about-fda/office-regulatory-affairs/ora-vision-mission-and-values

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Development Coordinator

US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
Nationwide

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