Job Listing
Deputy Director, Chief Medical Officer, Office of Product Evaluation and Quality
Food and Drug Administration · Posted 33 days ago
About the Role
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 .
What You'll Do
- →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.
Requirements
- ✓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.
- ✓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.
Personality Fit
Job ID: 4111a5a5-314d-4cd4-8955-b2216a512374
Posted via USAJobs