Radiologist (Breast Imaging)

Tunnell Government Services, Inc.; Silver Spring (MD); On-site; USD 150,000 - 200,000; Full time

Job summary

Tunnell Government Services, Inc. seeks a Medical Officer (Breast Imaging Radiologist) SME to support FDA CDRH regulatory activities. The role emphasizes expert clinical input, review writing, and data analysis for medical devices related to breast imaging.

Candidate must hold an MD with a US license, ABR radiology board certification, MQSA, and at least seven to ten years of breast imaging experience. 100% telework; US citizenship or green card required.

Qualifications

• MD from an accredited US medical school.
• Active, unrestricted medical license in a US jurisdiction.
• At least ten years of clinical experience.
• Fellowship in breast imaging or equivalent training.
• ABR certification; MQSA qualification.
• Understanding of radiology practices and breast imaging modalities.
• Experience with FDA medical device regulatory processes.

Responsibilities

• Provide expert consulting to assist CDRH with regulatory responsibilities.
• Support medical device reviews (EUA, 510(k), PME, De Novo) and participate in meetings.
• Develop written reviews, correspondence, and reports; perform data analysis.
• Coordinate meetings with internal and external stakeholders; communicate findings clearly.

Skills

MD

Medical license

Breast imaging radiology

MQSA qualification

ABR board certification

FDA regulatory knowledge

Written/verbal communication

Team collaboration

Education

Doctor of Medicine (M.D.)

Board certification in Radiology

Job description

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.

FDA CDRH – Medical Officer (Breast Imaging Radiologist) SME 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.

Tunnell Government Services is providing professional and scientific services to the 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; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office 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 training in clinical medicine and breast imaging radiology, as relevant to medical devices.

Requirements and Qualifications

• The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States
• In addition, the candidate must possess a 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 ten (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.)
• 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
• 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

This position is 100% telework.

Must be a US Citizen or 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Tunnell Government Services’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.