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 6, Band G .
Duties
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.
How you will be evaluated
You will be evaluated for this job based on how well you meet the qualifications above. This is a Title 21 announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. Please follow all instructions carefully. Errors or omissions may affect your eligibility.