Epidemiologist I- Full time-Public Health

Tunnell Government Services, Inc., is comprised of the industry's leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. Epidemiology Subject Matter Expert - 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 Clinical Evidence and Analysis within CDRH's Office of Product Evaluation and Quality (OPEQ) provides policy and program support regarding clinical trials, biostatistics, real-world evidence, epidemiological analysis and outreach and collaboration with hospitals and other external stakeholders.
Tunnell Government Services, Inc. is providing professional and scientific services to CDRH with expert consultants with scientific expertise in the regulation and approval and of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions); write detailed documents and reports; and execute other administrative tasks related to CDRH's projects.
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 applicable training in epidemiology, as relevant to:

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 the safety and effectiveness of medical devices, under the direction of federal personnel.
Post-Market Surveillance: Monitor medical devices already on the market 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: Use epidemiological methods to guide policy frameworks, ensuring that patients and healthcare providers have timely access to safe and effective devices
Risk/Benefit Analysis: Quantify the benefits and risks of innovative medical technologies, including AI and digital health applications
The ideal candidate will have a doctorate in an area of study such as Epidemiology, Applied Statistics, or Public Health.

• Possess several years of experience coordinating, conducting, and/or reviewing epidemiologic studies, surveys, and/or analyses to inform program and policy decisions.
• Regulatory Knowledge: An understanding of medical device regulations is preferred.
• The candidate must possess a bachelor's degree (BS) in a relevant field
• An advanced degree (MD, MS, PhD) in a related/applicable field is strongly preferred.
• 5-7 years of applicable experience is required, however advanced degrees can substitute for professional work experience
• Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.)

Job Type: Full Time
Schedule: Monday through Friday (No Holidays)
Location: This position is 100% telework.
Must be a US Citizen or a Full Green Card holder.
To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.