Epidemiologist

Tunnell Government Services, Inc. is an employee-owned company of leading scientists, medical and technical experts, and human capital professionals. We help clients transform and achieve strategic goals through innovative, integrated solutions.

About the role

The FDA Center for Devices and Radiological Health (CDRH) protects and promotes public health by ensuring timely access to safe, effective, and high-quality medical devices and radiation-emitting products. The Office of Clinical Evidence and Analysis within CDRH provides policy and program support on clinical trials, biostatistics, real-world evidence, epidemiological analysis, and stakeholder collaboration.

Tunnell is providing expert consulting services to CDRH with specialists in medical device regulation. Consultants support device reviews (EUA, 510(k), PMA, De Novo), participate in meetings, coordinate with stakeholders, develop reviews and reports, and perform related administrative tasks.

We seek an Epidemiology Subject Matter Expert to assist CDRH with regulatory responsibilities, focusing on:

• Evaluating the safety, effectiveness, and post-market performance of medical devices and radiation-emitting products
• Analyzing clinical trial data, real-world evidence (RWE), and adverse event reports
• Monitoring device safety and effectiveness under federal direction

Responsibilities

• Post-Market Surveillance: Monitor marketed medical devices to detect safety signals, assess risks, and investigate adverse events
• Clinical Trial & Study Design: Collaborate with biostatisticians and medical officers to review study protocols, clinical evidence, and real-world data (RWD)
• Regulatory Decision-Making: Apply epidemiological methods to guide policy frameworks and ensure timely access to safe, effective devices
• Risk/Benefit Analysis: Quantify benefits and risks of innovative medical technologies, including AI and digital health applications

Qualifications

• Doctorate in Epidemiology, Applied Statistics, Public Health, or a related field (strongly preferred)
• Bachelor’s degree (BS) in a relevant field (required)
• 5–7 years of applicable experience; advanced degrees may substitute for professional experience
• Experience coordinating, conducting, or reviewing epidemiologic studies, surveys, or analyses to inform policy decisions
• Understanding of medical device regulations (preferred)
• Excellent written and verbal communication skills
• Strong interpersonal skills; ability to work independently and within a technical team
• Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.)

Schedule

Full-time, Monday through Friday (no holidays). This position is 100% telework.

Must be a U.S. citizen or a full Green Card holder.