Remote Breast Imaging Radiologist & Regulatory Expert

Tunnell Government Services, Inc.; Silver Spring (MD); Remote; 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. 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.