Radiologist (Breast Imaging)

Tunnell Government Services • Bethesda, MD

9h • Remote

About The Position

Tunnell Government Services, Inc. is seeking a candidate to provide expert consulting services to assist the FDA Center for Devices and Radiological Health (CDRH) with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and breast imaging radiology, as relevant to medical devices. The mission of the FDA CDRH is to protect and promote the public health by assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Tunnell Government Services provides professional and scientific services to the CDRH with expert consultants in the regulation and approval of medical devices. 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; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office tasks related to CDRH’s projects.

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 seven (7) years of relevant clinical experience
• Fellowship or equivalent training in breast imaging and substantial professional experience in breast imaging
• Certification from a U.S. relevant specialty board organization (e.g., American Board of Radiology)
• Current qualification through the Mammography Quality Standards Act (MQSA)
• Thorough understanding of current clinical practices in radiology, including diagnosis and treatment, use of software to aid the radiologist, and current/emerging trends in practice
• Proficient in all aspects of breast imaging, including mammography, ultrasound, MRI and image-guided procedures
• Expert in function and utilization of medical devices commonly used as part of breast imaging radiology (e.g., imaging systems, image-guided intervention devices, localization devices, breast tissue marker devices, contrast agents, AI and advanced imaging software, 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
• Must be a US Citizen or full Green Card holder.

Nice To Haves

• Experience in clinical trial evaluation preferred: evaluating clinical trial designs, identification of appropriate study endpoints, review of study results is preferred
• Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 900 – Mammography, 21 CFR Part 892 – Radiology Devices), and guidances is preferred

Responsibilities

• 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
• Perform research
• Conduct data analysis
• Write detailed documents and reports
• Execute other administrative office tasks related to CDRH’s projects

What This Job Offers

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