FDA CDRH - Medical Officer (Gastroenterologist) SME Position Description

The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

The Office of Product Evaluation and Quality (OPEQ) is the office responsible for the evaluation of pre- and post-market submissions from the medical device industry. The office plans, coordinates, and renders Agency decisions regarding the approval, denial, and withdrawal of approval for companies to market medical devices in the United States. OPEQ also authorizes the conduct of clinical trials of unapproved medical devices under the Investigational Device Exemptions (IDE) program. The data gathered in these clinical studies is frequently used to support market authorizations.

Tunnell Government Services, Inc. is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval and of medical devices.The incumbent serves as an expert and clinical reviewer within OHT3. The incumbent uses significant knowledge of devices to evaluate the safety and efficacy of devices and clinical studies that are submitted to the Office. Reviews and analyzes IDEs, PMAs, 510(k)s, HDEs, Pre-Submissions, and other submissions for new technologies, devices and combination products. Provides expert clinical judgment related to post-market and compliance reviews (e.g., adverse event reports, recalls, allegations, Establishment Inspection Reports). Provides expert opinions and recommendations on medical devices which present difficult and important questions of review and evaluation of scientific data in the solution of problems related to the Medical Device User Act, FDA Safety and Innovation Act (FDASIA), the implementation of the Medical Device Amendment of the Federal Food, Drug and Cosmetic Act (FD&C), the Food and Drug Administration Modernization Act and the Radiation Control for Health and Safety of 1972 in the area of medical and radiation emitting device review products.

Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and gastroenterology, as relevant to medical devices.

This position is located in the Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Health Technology 3 (OHT3), Division of Renal, Gastrointestinal, Obesity & Transplant Devices/ Gastroenterology & Endoscopy Device.

Requirements and Qualifications

• The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States.
• In addition, the candidate must possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
• At least fifteen (15) years of relevant clinical experience
• Certification from a U.S. relevant specialty board organization, e.g., the American Board of Internal Medicine, Internal Medicine certification; the American Board of Internal Medicine, Gastroenterology certification
• Thorough understanding of current clinical practices in gastroenterology, including diagnosis and treatment, and current/emerging trends in practice.
• Knowledge of general anatomy and surgery involving the digestive system
• Knowledge of assessing patients with a variety of digestive disorders such as gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), and inflammatory bowel diseases like Crohn's disease and ulcerative colitis
• Knowledge of relevant diagnostic procedures such as endoscopy, colonoscopy, imaging (CT, MRI), etc.
• Knowledge of gastrointestinal medical devices such as endoscopes, capsule endoscopy systems, stents, electrosurgical units, etc.
• Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 876 - Gastroenterology-Urology Devices), and guidances is preferred.
• Ability to communicate well with others using excellent written and verbal communication skills.
• Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel (i.e., engineers, statisticians, biologists, etc.).

This position is 100% telework.

Must be a US Citizen or full Green Card holder.