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. OHT1/DHT1A is responsible for the total lifecycle (TPLC) review of ophthalmic medical devices.
Meet one of the faces behind CDRH here.
Position Summary: As an Ophthalmologist in OHT1, you will work together with engineers, statisticians, and other scientists to evaluate the safety and effectiveness of medical devices for their intended use and make the regulatory decisions that determine whether these devices can be made available to physicians and patients, either in clinical trials or via marketing approval. Specifically, you will be working on projects involving the full range of therapeutic, diagnostic, and combination (device/drug or device/biologic) devices.
Duties/Responsibilities: As an Ophthalmologist you will also:
- Review proposed clinical trial protocols to ensure that trials are capable of collecting valid scientific evidence while sufficiently protecting patient safety.
- Analyze the results of clinical trials to determine whether they support the safety and effectiveness of a given product.
- Develop scientifically sound clinical review policy for these devices, evaluation of post market device safety issues.
- Conduct outreach to device manufacturers and physician groups on clinical topics.
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:
- Knowledge of the regulatory total product lifecycle (TPLC) review process of ophthalmic medical devices including: implementation of premarket review programs (e.g., 510(k), PMA, HDE, DeNovo, IDE, etc.), compliance and quality programs (e.g., Establishment Inspection Report, Regulatory Audit Reports, Recalls, Allegations of Regulatory Misconduct, Labeling, Enforcement Actions, etc.), and surveillance programs (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals, etc.).
- 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, etc.).
- Ability to interpret and assess scientific data and technical reports to determine the safety and effectiveness of medical products.
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.
- Conditions of Employment:
- United States Citizenship is required.
- One-year probationary period may be required.
- Background and/or security investigation required.
- All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption.
- 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 website.
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.
- 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.