Remote Breast Imaging Radiologist – FDA Regulatory SME

Tunnell Government Services, Inc.; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Tunnell Government Services, Inc. seeks a Medical Officer (Breast Imaging Radiologist) SME to support FDA CDRH regulatory reviews. The role focuses on clinical breast imaging and radiology expertise applied to medical devices, with telework arrangements.

The candidate will provide expert consulting, participate in reviews and meetings, and develop written analyses, reports, and recommendations for device submissions and regulatory decisions.

Qualifications

• MD/DO with US medical licensure and board certification in radiology.
• At least seven years of clinical experience in breast imaging.
• Fellowship training in breast imaging; MQSA qualification.
• Familiarity with FDA medical device regulations and radiology guidelines.

Responsibilities

• Provide expert consulting to assist CDRH regulatory responsibilities.
• Develop written reviews, reports and correspondence for device submissions.
• Participate in meetings and teleconferences with stakeholders.
• Coordinate and conduct data analysis related to radiology device applications.

Skills

Breast imaging expertise

Mammography

Ultrasound

MRI

Image-guided procedures

Regulatory knowledge (FDA/21 CFR)

Education

Doctor of Medicine (M.D.) from a US-accredited medical school

Active medical license in US jurisdiction

7+ years of relevant clinical experience

Fellowship/training in breast imaging

Board certification (e.g., American Board of Radiology)

MQSA qualification

Job description

Tunnell Government Services, Inc. seeks a Medical Officer (Breast Imaging Radiologist) SME to support FDA CDRH regulatory reviews. The role focuses on clinical breast imaging and radiology expertise applied to medical devices, with telework arrangements.

The candidate will provide expert consulting, participate in reviews and meetings, and develop written analyses, reports, and recommendations for device submissions and regulatory decisions.