Heart Failure Cardiologist & Regulatory SME (Remote)

Tunnell Government Services, Inc.; Oregon; Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

100% telework

Job summary

Tunnell Government Services, Inc. seeks a Cardiologist (Heart Failure SME) to support FDA CDRH regulatory reviews related to cardiovascular devices.

The role requires deep clinical expertise and the ability to translate medical insights into regulatory documents. Candidates must be US physicians with active licensure, board certification in cardiology, and extensive experience in advanced heart failure and transplant cardiology.

Qualifications

• MD from an accredited US medical school.
• Active, unrestricted medical license to practice in the United States.
• Minimum fifteen (15) years of relevant clinical experience.
• Board certification in cardiology (e.g., ABIM, ACC).
• Specialized qualifications in Advanced Heart Failure and Transplant Cardiology.
• Thorough understanding of cardiovascular medicine and devices used in care.

Responsibilities

• Provide expert consulting to assist FDA CDRH with regulatory responsibilities for cardiovascular devices.
• Coordinate meetings with internal and external stakeholders; develop written reviews and reports.
• Perform data analysis and write detailed documents and reports related to regulatory reviews.

Skills

Clinical communication

Team collaboration

Regulatory knowledge

Medical device familiarity

Project coordination

Education

Doctor of Medicine (M.D.)

Medical license (US)

Fifteen years of clinical experience

Board certification in cardiology

Advanced Heart Failure and Transplant Cardiology fellowship

Job description

Tunnell Government Services, Inc. seeks a Cardiologist (Heart Failure SME) to support FDA CDRH regulatory reviews related to cardiovascular devices.

The role requires deep clinical expertise and the ability to translate medical insights into regulatory documents. Candidates must be US physicians with active licensure, board certification in cardiology, and extensive experience in advanced heart failure and transplant cardiology.