Deputy Director, Chief Medical Officer, Office of Product Evaluation and Quality

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 . In order to qualify for the Deputy Director, Chief Medical Officer, Office of Product Evaluation and Quality position which falls under the 0602 occupational Series, you must meet the following requirements by 11:59 pm EST on 09/13/2026: 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 Deputy Director, Chief Medical Officer position, you must meet the Education Requirement listed in the Education section below. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Minimum 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. Organizational Management: Assists in managing an Office. Program Management: Runs a multi-disciplinary program in the Center. May run two or more smaller, multi-disciplinary programs in the Center. Identifies specific activities needed to achieve desired outcomes. Organizational staffing patterns are primarily homogeneous, but may also have staff in various scientific, professional, technical, or administrative occupational series. Resource Management: Considers external resource relationships, identifying new, innovative ways to overcome resource constraints, possibly by collaborating with other, similar resource-consuming activities. Human Capital Management: Advises on organizational capabilities and the appropriate human competencies needed to support those capabilities. Provides reasonable accommodations needed to best utilize qualified people with disabilities. 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. 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. Education 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. Education Requirements: Degree: Doctor of Medicine, Doctor of Osteopathic Medicine or equivalent from a school in the United States or Canada. This degree must have been accredited by the Council on Medical Education of the American Medical Association(external link); Association of American Medical Colleges(external link); Liaison Committee on Medical Education(external link); Commission on Osteopathic College Accreditation of the American Osteopathic Association(external link), or an accrediting body recognized by the U.S. Department of Education(external link) at the time the degree was obtained. Degree from Foreign Medical School: A Doctor of Medicine or equivalent degree from a foreign medical school must provide education and medical knowledge equivalent to accredited schools in the United States. Evidence of equivalency to accredited schools in the United States is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates(external link), a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country, or successful completion of the U.S. Medical Licensing Examination. Licensure For all grade levels and positions, applicants must possess a current, active, full, and unrestricted license or registration as a Physician from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0600/physician-series-0602/ 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. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements. Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access. Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation. To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded. Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below: National Association of Credential Evaluation Services (NACES) Association of International Credentials Evaluators (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.