Travel Requirements: This position requires occasional travel.
Application Period: October 27, 2021 through November 26, 2021
Salary: Salary is equivalent to GP-0602-14, plus physician market pay (Title 38), and is commensurate with education/experience. U.S. Public Health Service Commissioned Corps Officers may also apply.
Introduction: The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe and effective. The mission of CDRH is to protect and promote the public health by performing essential public health tasks by making sure that medical devices and radiological health products are safe for people in the United States. OHT3 for the in vitro diagnostic, radiological health, and mammography quality standards programs. DHT3A is responsible for the total lifecycle (TPLC) review of renal, gastroenterology, obesity and transplant devices.
Position Summary: As a Physician (Gastroenterologist) in OHT3, you will work together with a multi-disciplinary staff participating in the review of medical devices to determine their safety and effectiveness prior to and after their introduction to the marketplace. Specifically, you will have a significant role in clinical trial study design, while also analyzing and interpreting clinical data and providing written and verbal recommendations on submissions. Duties/Responsibilities: As a Physician (Gastroenterologist) you will also:
Provide expert medical expertise with regard to Office programs and policies concerning premarket review, compliance and quality, and postmarket surveillance activities.
Provide expert clinical perspective on safety and effectiveness of various gastroenterological medical devices throughout the total product lifecycle.
Collaborate with clinical investigators and representatives of regulated industry.
Review and evaluate design, test, and production data and reports from various gastroenterological device manufacturers to ensure compliance with promulgated standards and regulations.
Complete data analysis on clinical reports and integrate data derived from medical literature, FDA adverse experience reports, material submitted to FDA on similar or analogous substances, results of field surveys by FDA District Offices and consults with authorities in the pertinent fields.
Professional Experience/Key Requirements: To qualify for this position, you must demonstrate in your resume the necessary experience for this position, which is equivalent to the following:
Board eligible or certified in gastroenterology or have completed a minimum of three years of fellowship training in gastroenterology or possess equivalent experience.
Expert knowledge of gastroenterological medical products, and an up-to-date working knowledge of the medical research design and methods, procedure, and techniques related to the regulation of gastroenterological medical device submissions.
Ability to collaborate with a multi-disciplinary staff responsible for scientific, public health and/or regulatory activities associated with medical products (i.e., devices, biologicals, drugs, ).
Ability to effectively interpret, assess and present complex scientific, technical, clinical, and regulatory information and concepts, in both written and oral formats for a variety of audiences.
Basic Qualifications: Physician, GP-0602: Must be a U.S. citizen with Doctor of Medicine (M.D.), Doctor of Osteopathic Medicine (D.O.) or equivalent from a school in the United States or Canada. The degree must have been approved by a recognized accrediting body at the time the degree was obtained.
A Doctor of Medicine or equivalent degree from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States may be demonstrated by the Educational Commission for Foreign Medical Graduates, or a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country. Candidates for Civil Service or U.S. Commissioned Corps must possess a valid license to practice medicine in any state in the U.S. It is highly desired that the prospective candidate has eligible Board Certification.
Licensure: Applicant 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.
This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office
How to Apply: If you’re seeking a challenging and rewarding career opportunity, we invite you to apply today by completing the following steps:
Submit your electronic resume or curriculum vitae to CDRH Recruitment at CDRHRecruitment@fda.hhs.gov. Reference Job Code: 2020-OHT3-DHT3A-017.
Create/Log-in to your USAJOBS account and review the official job opportunity announcement located on USAJobs.gov here. Applications MUST be received by applying to the official job opportunity announcement.
Required documentation should include: a copy of your current, active, unrestricted medical license and a copy of your Doctor of Medicine transcripts (official/unofficial) or ECFMG. Your transcripts must show completion/conferred date. Additional supporting documentation may include: bibliography, summary of research accomplishments, and names/contact information of three references.
The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.