Medical Officer - Gastroenterologist

Tunnell Government Services • Bethesda, MD

10d • Remote

About The Position

Tunnell Government Services, Inc. is seeking a Medical Officer with expertise in Gastroenterology to provide professional and scientific services to the FDA's Center for Devices and Radiological Health (CDRH). This role involves serving as an expert clinical reviewer within the Office of Health Technology 3 (OHT3), evaluating the safety and efficacy of medical devices and clinical studies submitted to the Office. The incumbent will review various submissions including IDEs, PMAs, 510(k)s, HDEs, and Pre-Submissions. Additionally, the role requires providing expert clinical judgment on post-market reviews, such as adverse event reports and recalls, and offering expert opinions on complex medical device issues related to relevant legislation. The position is 100% telework.

Requirements

• Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States.
• 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.
• 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.).
• Must be a US Citizen or full Green Card holder.

Nice To Haves

• Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 876 – Gastroenterology-Urology Devices), and guidances is preferred.

Responsibilities

• Serve as an expert and clinical reviewer within OHT3.
• Evaluate the safety and efficacy of medical devices and clinical studies submitted to the Office.
• Review and analyze IDEs, PMAs, 510(k)s, HDEs, Pre-Submissions, and other submissions for new technologies, devices, and combination products.
• Provide expert clinical judgment related to post-market and compliance reviews (e.g., adverse event reports, recalls, allegations, Establishment Inspection Reports).
• Provide expert opinions and recommendations on medical devices which present difficult and important questions of review and evaluation of scientific data.
• Assist the CDRH with their regulatory responsibilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree