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.

Introduction
The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco, and radiation emitting devices safe, and that all such products marketed in the United States are adequately, truthfully, and informatively labeled and safely and properly
stored, transported, manufactured packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multibillion dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.


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).
The Office of Medical Products and Tobacco Operations (OMPTO) has responsibility for inspections, investigations, compliance and enforcement of medical products and tobacco facilities regulated by the Medical Products and Tobacco Centers.

The incumbent is expected to have knowledge of ORA inspections of regulated products and manufacturers, provides expert advice and counsel to the Assistant Commissioner for Medical Products and Tobacco Operations (ACMPTO) and other Agency leaders on inspectional and compliance operations, training needs and emergency response activities related to advanced manufacturing and medical countermeasure regulated products.


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

Requirements

Duties/Responsibilities
The Regulatory Program Manager develops, implements, and evaluates programs and projects; designs, plans, develops and enhances OMPTO projects and programs of high visibility, conducts special studies, meets, and consults with heads of various agency functions and provides consultation and expert advice in the coordination of projects between several different organizations. Additionally, the regulatory program manager:
• Manages activities and resources of cross-functional project teams; establish project plans and monitor project/program milestones and deliverables.
• Develops written project progress reports and oral presentations for internal and external stakeholders.
• Serves as primary point of contact for the up-to-date status of project progress and representing the team activities to management and/or external partners. Proactively advises senior leaders on recommendations for program improvements related to individual and overall project planning.
• Monitors and reports actual status of all activities within the assigned projects through interaction with project participants and, if required, supervisors and directors. Ensures
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timelines and deliverables are met and raises any matters or issues to the Associate Director for Advanced Medical Products Manufacturing (AMPM). • Serves as an ORA contact point for all project communications concerning advanced manufacturing / MCM operational and regulatory policy activities. Ensures ORA’s priorities are aligned and reflected in in the overall advancement of modern, emerging, and advance technology through proactive and sustained collaboration
• Leads, manages, and facilitates the work of individual projects collaboratively.
• Interfaces with Center Regulatory Project Managers to ensure advanced awareness of AM/MCM related activities and coordinate operational engagement.
Conditions of Employment
• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Males born after December 31, 1959 must be registered with the Selective Service.
• One-year probationary period may be required.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Background Investigation/Security Clearance is required. All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
Qualifications
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 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.
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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 man and qualitative and quantitative analytical methods and techniques to provide the Office Program Directors, ACMPTO and other senior staff of ORA with 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

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Regulatory Program Manager

FDA Office of Regulatory Affairs
Nationwide

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