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. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us. 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); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; 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.

Key Duties and Responsibilities 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 Qualifications 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 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. 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. Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. 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. Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.