Cardiologist (Heart Failure SME)

Tunnell Government Services • Bethesda, MD

2d • Remote

About The Position

Tunnell Government Services is seeking a cardiologist with expertise in Advanced Heart Failure and Transplant Cardiology to provide consulting services to the FDA Center for Devices and Radiological Health (CDRH), Office of Cardiovascular Devices. The role supports CDRH’s regulatory responsibilities and medical device reviews, including applications and submissions such as EUA, 510(k), PMA, HDE, De Novo, pre-submissions, Investigational Device Exemptions, and recalls.

The consultant may participate in meetings and teleconferences; coordinate with internal and external stakeholders; prepare written reviews, correspondence, detailed documents, and reports; conduct research and data analysis; and perform related administrative office tasks. The position is 100% telework. Candidates must be U.S. citizens or full Green Card holders. Client contracts may specify onsite requirements, and employees or contractors must comply with applicable client safety and health protocols.

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 in a U.S. state, the District of Columbia, Puerto Rico, or a U.S. territory.
• At least 15 years of relevant clinical experience.
• Certification from a relevant U.S. specialty board organization.
• Specialized qualifications in Advanced Heart Failure and Transplant Cardiology, such as a completed fellowship or clinical practice in Advanced Heart Failure/Heart Transplantation.
• Thorough understanding of current clinical practices in cardiovascular medicine, including diagnosis, treatment, and current and emerging practice trends.
• Expertise in the function and utilization of cardiovascular and/or interventional medical devices, including non-invasive diagnostic devices and instruments, implantable devices, and surgical systems.
• Excellent written and verbal communication skills.
• Excellent interpersonal skills and ability to work effectively both independently and on a team with technical personnel.
• Must be a U.S. citizen or full Green Card holder.

Nice To Haves

• Familiarity with FDA medical device regulatory processes, regulations such as 21 CFR Part 870 (Cardiovascular Devices), and related guidance.

Responsibilities

• Provide expert consulting services to assist CDRH with its regulatory responsibilities.
• Support medical device reviews, including EUA, 510(k), PMA, HDE, and De Novo marketing applications, pre-submissions, Investigational Device Exemptions, and recalls.
• Participate in meetings and teleconferences and coordinate meetings with internal and external stakeholders.
• Develop written reviews and correspondence.
• Perform research and data analysis.
• Write detailed documents and reports.
• Execute other administrative office tasks related to CDRH projects.

What This Job Offers

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