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 1, Band F. Serves as top scientific and technical expert and advisor and is nationally and internationally recognized authority in professional healthcare and medical related work spanning multiple disciplines with the health sciences. Provide scientific and technical leadership and guidance on regulations and policy issues, and federal laws (including the Food, Drug, and Cosmetic Act). Oversee OCEA regulatory and scientific work including developing policy and program support regarding clinical evidence, supporting device reviews that require expert clinical and real-world evidence analysis, and providing data infrastructure, management and analysis for clinical and real-world evidence. Provide scientific and technical consultation to the OCEA Director and other high-level officials in CDRH, FDA, PHS and HHS on program status, plans, trends and significant problems. Leads, manages and sets strategy for the OCEA. Ensures that OCEA activities are aligned with the goals and priorities of OPEQ. Supervisory Responsibilities: Provides technical, policy and administrative leadership, supervision and direction to the subordinate staff of the Office through subordinate supervisors. Exercises the full range of first and second-level supervisory responsibilities. Exercises significant responsibilities in dealing with officials of other units or organizations, or in advising management officials of higher rank. Works with the Office Director on the development, establishment, and clearance of goals, objectives, and strategic plans for the Office.

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