Director, Office of Science and Engineering Laboratories (OSEL)

Summary

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.

Duties

• •Provides executive leadership overseeing multidisciplinary programs in physical sciences, engineering, biological sciences, and computational science applied to the safety and effectiveness of medical devices and radiation-emitting products.
• •Set scientific strategy for OSEL, aligning priorities with CDRH and FDA-wide goals and anticipating emerging technologies and regulatory challenges.
• •Lead cutting-edge research programs that develop the test methods, measurement frameworks, computational models, and scientific tools that underpin FDA's regulatory decisions.
• •Advise senior leadership, including the CDRH Director, on significant scientific and engineering matters affecting medical device regulation.
• •Shape regulatory science as a discipline by establishing novel frameworks and methodologies adopted across FDA and by domestic and international regulatory partners.
• •Build strategic partnerships with federal agencies, industry, standards organizations, international counterparts, and academia.
• •Manage a highly skilled workforce spanning multiple laboratories and scientific disciplines.

Qualifications

In order to qualify for the Director, Office of Science and Engineering Laboratories (OSEL) position which falls under the 1301 occupational Series, you must meet the following requirements by 11:59 pm EST on 10/28/2026: The candidate must meet the following qualifications for this Title 21 position: Scientific, Technical, and/or Professional Fields Qualified and Outstanding Candidates a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the technical qualifications defined below 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. Minimum Qualifications: To qualify for a Band G Director, Office of Science and Engineering Laboratories (OSEL) position, you must meet the Education Requirement listed in the Education section below. Desired Qualifications: Possesses a Ph.D. in the life sciences or an M.D./Ph.D. degree, with advanced research and scientific training relevant to the position. The preferred qualification reflects the depth of research expertise needed to lead multidisciplinary regulatory science programs and address complex scientific and emerging technologies. An M.D. without a Ph.D. is not considered equivalent to the preferred research and scientific background. This position is designated as an SES Equivalent position and is covered under the FDA Title 21 Executive Performance Management System and identified as a public filing position for ethics purposes. While PHS Commissioned Corps Officers cannot hold a Title 21 position during their active service as PHS Officers, we welcome and encourage them to apply-their applications will receive full consideration. Please note that if selected, the Officer will need to end their Commissioned Corps appointment before being placed in the Title 21 position. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. Supervisory Responsibilities The incumbent is delegated full authority to achieve group goals and objectives through the effective management of available resources. Performance and accomplishments are assessed primarily through work performance indicators, staff discussion, planning sessions, review of individual project outputs, and annual program review. Leads in a proactive, customer-responsive manner consistent with Agency vision and values, effectively communicating program issues to external audiences. Ensures financial and managerial accountability by acting with prudence when executing fiduciary responsibilities. Demonstrates high integrity and adheres to the highest ethical standards of public service. Uses effective business practices including balanced measures of results, values, and invests in each employee; emphasizes empowerment and two-way communication. Takes a leadership role in advocating for and advancing the priorities of the Agency. Serves as a role model for leadership by encouraging teamwork and a collaborative approach. Timely notifies Agency officials of all significant actions and developments, including but not limited to those related to regulatory matters, legislative matters, budget matters, reports, initiatives, and events and ensures subordinate managers do the same. Provides reasonable accommodations needed to best utilize qualified people with disabilities. Organizational Management: Manages the Office of Science and Engineering Laboratories (OSEL) within CDRH to sustain and advance a preeminent regulatory science enterprise capable of addressing frontier scientific challenges at the forefront of medical device regulation. Establishes strategic direction and priorities across OSEL's scientific programs spanning life sciences, biological sciences, engineering, physical sciences, and computational sciences. Ensures alignment of OSEL's organizational objectives with CDRH and FDA-wide priorities and regulatory mission. Program Management: Runs a multidisciplinary regulatory science program in the Center encompassing multiple laboratories and scientific disciplines. Directs and evaluates activities addressing scientific and technical questions relevant to medical devices and radiation-emitting products, including test methods, biocompatibility, biological testing, in vitro/in vivo evaluation, computational modeling, and reference materials. Establishes new scientific programs and frameworks in areas without precedent, shaping how emerging and complex technologies are evaluated across the regulatory enterprise. Oversees a highly diverse workforce across scientific, professional, technical, and administrative occupational series. Resource Management: Monitors and reports on resources needed to lead strategic resource planning for OSEL and its multidisciplinary regulatory science programs. Establishes annual and multi-year objectives, determines program priorities, and allocates resources across OSEL's scientific programs. Evaluates the effectiveness and regulatory impact of OSEL programs to inform resource planning and ensure efficient use of available resources in support of CDRH's regulatory mission. Human Capital Management: Identifies employee competencies necessary to meet OSEL's organizational capabilities goals across its multidisciplinary scientific workforce. Designs competency frameworks and workforce architecture to ensure OSEL maintains the scientific capabilities needed for current and emerging regulatory science challenges. Promotes employee development and identifies workforce and succession needs to ensure OSEL maintains the scientific knowledge, methods, tools, and capabilities required to address current and emerging regulatory challenges. Provides leadership to subordinate managers and supervisors and ensures effective and equitable management of the organization.

Education

Education Requirements: Degree: physical science, engineering, or mathematics that included 24 semester hours in physical science and/or related engineering science such as mechanics, dynamics, properties of materials, and electronics OR Combination of education and experience -- education equivalent to one of the majors shown in A above that included at least 24 semester hours in physical sci