13 days old

Program Expert for Advanced Manufacturing

Nationwide
  • Job Type
    Employee
  • Job Status
    Full Time

As a Program Expert for Advanced Manufacturing, the incumbent serves as a subject matter expert in inspectional and investigational techniques and provides authoritative advice to ORA senior leadership in advanced manufacturing for medical products. Additionally, the program expert:
• Collaborates with industry groups, professional organizations, and academia to evaluate and leverage training expertise from outside FDA
• Develops and recommends regulatory and operational science policy concepts to the Staff Director, Associate Director for Advanced Medical Products Manufacturing and other OMPTO senior managers.
• Engages with various stakeholders (industry, academia, foreign regulatory authorities) to keep abreast of emerging product technologies, advanced manufacturing process, innovative control and testing strategies and novel platform technologies. Proactively provides advice and counsel to Associate Director for Advanced Medical Products Manufacturing and other Agency leaders on medical products regulatory operations and operational policy to ensure inspectional activities keeps pace with industry advancements.
• Engages early with Centers on advanced manufacturing initiatives to identify novel technologies in the pipeline and to understand technical and regulatory issues with advanced manufacturing to help dictate and inform operational policies.
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• Incorporates learnings from internal and external engagement activities into ORA’s investigator training programs utilizing public / private partnerships and/or contracts as warranted.
• Provides technical advice and guidance to other investigators and industry representative regarding inspectional and investigational techniques. Evaluate complicated programs and situations to objectively analyze relevant information to devise acceptable solutions as necessary. Formulate and develop inspectional and investigational procedures and techniques based on background and understanding of policies, regulations, procedures, and information.
• Conducts complex and technical inspections and investigations which require extensive scientific knowledge of inspectional work associated with pharmaceutical, biologics and medical device inspections.
• Collaborates with and provides program expert subject matter guidance to the Training Officer in the design and formulation of nationwide training programs for inspection employees. As assigned, may serve as course instructor, director, or monitor.
• Provides a focal point within FDA to whom the headquarters and field service may turn for authoritative guidance and consultation regarding inspectional and investigational methods and procedures necessary to accomplish compliance objectives. Mentors field inspection and investigation staff to ensure they receive the correct mix of formal and on-the-job training with respect to emerging technologies, advanced medical product manufacturing process, innovative control and testing strategies and novel platform technologies regulated by FDA.

Requirements

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.
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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.
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
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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 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: 2022-11-15 Expires: 2022-12-15

FDA Office of Regulatory Affairs

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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Program Expert for Advanced Manufacturing

FDA Office of Regulatory Affairs
Nationwide

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