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 6, Band G . Serves as Deputy Director and Chief Medical Officer for OPEQ, providing executive leadership and strategic direction for FDA medical device programs. Serves as OPEQ's senior clinical authority, providing expert guidance on complex clinical, scientific, regulatory, and public health issues. Oversees premarket and postmarket medical device review, including 510(k)s, PMAs, De Novo requests, IDEs, and postmarket surveillance. Leads clinical oversight of regulatory decisions affecting the safety, effectiveness, quality, and performance of medical devices. Provides benefit-risk expertise for premarket and postmarket regulatory decision-making involving medical devices. Advises on novel, high-risk, and precedent-setting medical technologies and complex regulatory issues. Leads evaluation of emerging medical device technologies and supports regulatory approaches that keep pace with scientific advances. Oversees identification, assessment, and resolution of significant medical device safety issues. Directs development and implementation of clinical and scientific regulatory policy, guidance, and frameworks. Represents OPEQ, CDRH, and FDA with Congress, government officials, industry, healthcare professionals, academia, and international regulators. Provides expert advice on medical device issues of significant public health importance. Shares executive leadership for an organization of more than 1,500 employees, overseeing clinical, scientific, regulatory, and operational programs. Establishes organizational priorities and promotes scientific excellence, innovation, collaboration, and workforce development. Advises the OPEQ Director on organizational strategy, policy, resource allocation, and emerging public health issues. Helps shape the future direction of FDA medical device evaluation and regulation in support of the agency's public health mission.

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