Physician (Ophthalmologist - Glaucoma Specialist)
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
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 Center for Devices and Radiological Health (CDRH or Center) serves as the medical devices regulatory arm of the FDA and the Department of Health and Human Services (HHS). 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.
The Office of Product Evaluation and Quality (OPEQ) assures patients have access to high quality, safe, and effective medical devices and products throughout the total product lifecycle (TPLC) by implementing program areas through which medical devices are evaluated or cleared for clinical investigations and marketing. The Office of Health Technology I (OHT1), within OPEQ, is responsible for the TPLC review of ophthalmic, anesthesia, respiratory, ear, nose, and throat (ENT), and dental medical devices. This includes development and implementation of policies related to human subject protection, good clinical practice, and appropriate collection of real-world evidence (RWE).
Duties/Responsibilities
The Physician (Ophthalmologist) reports directly to the OHT1/DHT1A (Division of Ophthalmic Devices) Assistant Director and serves as the clinical and technical expert in the field of Ophthalmology, specifically glaucoma. The Physician, Glaucoma Specialist, provides clinical, scientific, and technical leadership and expertise in policies and procedures with an emphasis on testing, evaluation, and quality control standards regarding ophthalmic medical devices, to include surgical instrumentation, ocular implants, and other products and diagnostic equipment used in the diagnosis and treatment of glaucoma.
- Serves as an authority on the latest developments in health care policy and the ophthalmic medical device industry. As such, conducts regulatory policy reviews related to the development aspects of medical devices, diagnostic equipment, and products used in the practice of Ophthalmology.
- Utilizes clinical expertise and technical knowledge to serve as an authoritative voice and principal advisor to the DHT1A Assistant Director and the OHT1 Office Director on matters regarding ophthalmic medical devices, diagnostic equipment, and products, encompassing the entire product lifecycle.
- Offers evidence-based recommendations regarding classification and petitions for the reclassification of new ophthalmic medical devices, as well as identifies areas where standards need to be developed.
- Develops guidelines for the study and development of ophthalmic medical devices and products classified in the premarket approval space.
- Provides guidance to industry to ensure approaches to research studies follow FDA regulatory protocols for novel and predicate ophthalmic medical devices and products.
- Evaluates proposed clinical trial protocol(s) for their ability to assess the safety, effectiveness, and reliability of new ophthalmic medical devices under development.
- Evaluates ophthalmic medical device clinical trial findings, risk to benefit data, scientific properties, safety data, and the overall impact of existing devices, as well as new technologies submitted to the Center.
- Supports review staff by sharing clinical expertise in the pre-market, compliance, and post-market surveillance spaces, as well as regulatory policy knowledge and interpretation.
- Reviews and assesses the safety implications from post-market surveillance data and adverse event reports and recommends appropriate regulatory courses of actions.
- Coordinates, carries out, and makes post-market compliance and quality determinations (e.g., Establishment Inspection Report, Regulatory Audit Reports, Recalls, Allegations of Regulatory Misconduct, Labeling, Enforcement Actions, etc.)
- Coordinates, carries out, and makes post market surveillance determinations (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals, etc.)
How to Apply
Submit resume and cover letter by November 7, 2023, to CDRHRecruitment@fda.hhs.gov Please adhere to the following submission protocol:
- Cover letter and resume should be one combined PDF document.
- Please reference DHT1A-OHT1 Physician September 2023 in the subject line of your email submission.
Candidate resumes may be shared with hiring official within the CDRH with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.
PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply to this announcement. Officers must follow the instructions for how to apply and include their most recent orders in addition to the required documents. If selected, candidates will be referred to (CC) personnel and not as candidates for a Cures appointment.