Job Listing
Office Director, Office of Health Technology IV
Food and Drug Administration · Posted 63 days ago
About the Role
This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 4, Band G.
What You'll Do
- →Directs the Office of Health Technology 4 (OHT4) which oversees the regulation of surgical and infection control medical devices.
- →Establishes scientific policy, regulatory guidance, and technical direction for surgical and infection control medical devices across the total product lifecycle.
- →Leads development and execution of Office programs, strategic initiatives, and long- and short-term organizational goals aligned with Center priorities.
- →Provides leadership, supervision, and performance oversight for OHT4 managers and staff while fostering scientific excellence and operational effectiveness.
- →Serves as a nationally recognized expert in total product lifecycle (TPLC) regulation of surgical and infection control medical devices.
- →Directs end-to-end medical device review programs from premarket evaluation through postmarket surveillance and compliance activities.
- →Oversees premarket review programs, including 510(k), PMA, HDE, De Novo, IDE, and 513(g) submissions.
- →Directs OHT4 compliance programs involving inspections, recalls, labeling, enforcement actions, regulatory audits, and misconduct investigations.
- →Oversees OHT4 postmarket surveillance programs, including Medical Device Reports, safety signal assessments, 522 studies, and post-approval studies.
- →Analyzes compliance and performance data to inform regulatory decisions and support Office and Center initiatives.
- →Reviews and approves complex medical device regulatory decisions to ensure compliance with applicable laws, regulations, and scientific standards.
- →Serves as a principle advisor to OPEQ leadership on scientific, regulatory, operational, and strategic matters regarding the regulation of surgical and infection control medical devices.
Requirements
- ✓Ethics Clearance Requirements This position requires financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation.
- ✓If you are hired, you may be required to divest of certain financial interests.
- ✓You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.
- ✓For more information, please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
- ✓Education Requirements: Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the position.
- ✓This degree must be from an educational program from an accrediting body recognized by the U.S.
- ✓Department of Education(external link) at the time the degree was obtained. https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0600/general-medical-and-healthcare-series-0601/ Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required.
- ✓Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.
- ✓TRANSCRIPTS (Required): Positions which are scientific or technical in nature often have very specific educational requirements.
- ✓You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.
- ✓Education must be accredited by an accrediting institution recognized by the U.S.
- ✓Department of Education in order for it to be credited towards qualifications.
- ✓Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S.
- ✓Department of Education.
Personality Fit
Job ID: 1d85202d-2860-4310-9fff-efe0c215ddb5
Posted via USAJobs