Medical Officer - Gastroenterologist

About the role

Tunnell Government Services, Inc. is providing professional and scientific services to the FDA Center for Devices and Radiological Health (CDRH) with expert consultants specializing in the regulation and approval of medical devices. The incumbent serves as an expert clinical reviewer within the Office of Health Technology 3 (OHT3), evaluating the safety and efficacy of devices and clinical studies submitted to the Office.

The mission of CDRH is to protect and promote public health by ensuring 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 responsible for evaluating pre- and post-market submissions from the medical device industry, rendering Agency decisions on approvals, and authorizing clinical trials under the Investigational Device Exemptions (IDE) program.

The role involves reviewing and analyzing submissions such as IDEs, PMAs, 510(k)s, HDEs, Pre-Submissions, and other materials for new technologies, devices, and combination products. The incumbent provides expert clinical judgment on post-market and compliance reviews, including adverse event reports, recalls, and allegations, and offers recommendations on complex regulatory and scientific issues.

Responsibilities

• Evaluate the safety and efficacy of medical devices and clinical studies submitted to CDRH.
• Review and analyze submissions including IDEs, PMAs, 510(k)s, HDEs, Pre-Submissions, and other regulatory documents.
• Provide expert clinical judgment related to post-market and compliance reviews (e.g., adverse event reports, recalls, allegations, Establishment Inspection Reports).
• Offer expert opinions and recommendations on medical devices presenting complex regulatory and scientific challenges.
• Assess scientific data in alignment with regulations such as the Medical Device User Act, FDA Safety and Innovation Act (FDASIA), and the Medical Device Amendment of the Federal Food, Drug, and Cosmetic Act (FD&C).

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 to practice medicine in a U.S. state, District of Columbia, Commonwealth of Puerto Rico, or a U.S. territory.
• At least fifteen (15) years of relevant clinical experience.
• Certification from a U.S. relevant specialty board organization (e.g., American Board of Internal Medicine, Gastroenterology certification).
• Thorough understanding of current clinical practices in gastroenterology, including diagnosis, treatment, and emerging trends.
• Knowledge of general anatomy and surgery involving the digestive system.
• Experience assessing patients with digestive disorders such as gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), and inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis).
• Knowledge of diagnostic procedures such as endoscopy, colonoscopy, and imaging (CT, MRI).
• Familiarity with gastrointestinal medical devices (e.g., endoscopes, capsule endoscopy systems, stents, electrosurgical units).
• Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 876 – Gastroenterology-Urology Devices), and guidances is preferred.
• Must be a U.S. citizen or full Green Card holder.

Skills

• Excellent written and verbal communication skills.
• Strong interpersonal skills with the ability to work independently and collaboratively within a multidisciplinary team (e.g., engineers, statisticians, biologists).

Schedule

This position is 100% telework.