Interventional Cardiologist

Tunnell Government Services • Bethesda, MD

11h • Remote

About The Position

Tunnell Government Services is seeking an Interventional Cardiologist to provide expert consulting services to the FDA Center for Devices and Radiological Health (CDRH), Office of Cardiovascular Devices. The role supports CDRH’s regulatory responsibilities and requires expertise and training in clinical medicine and cardiology as relevant to medical devices.

Consulting work generally supports medical device reviews, including EUA, 510(k), PMA, HDE and De Novo marketing applications, pre-submissions, Investigational Device Exemptions, and recalls. Work may also include participating in meetings and teleconferences, coordinating meetings with internal and external stakeholders, developing written reviews and correspondence, conducting research and data analysis, writing detailed documents and reports, and completing related administrative office tasks. The position is 100% telework, though employees and contractors must comply with any client contract requirements for onsite work and applicable 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 physician registration to practice in a U.S. state, the District of Columbia, the Commonwealth of Puerto Rico, or a U.S. territory.
• At least 15 years of relevant clinical experience.
• Certification from a relevant U.S. specialty board organization, such as the American Board of Internal Medicine, American College of Cardiology, or ABIM Interventional Cardiology.
• Specialized training and experience in interventional cardiology, such as completion of an Interventional Cardiology fellowship and clinical practice or advanced training in minimally invasive, catheter-based procedures including cardiac catheterization, PCI, or TAVR.
• Thorough understanding of current clinical practices in cardiovascular medicine, including diagnosis, treatment, and current or emerging practice trends.
• Expertise in the function and utilization of cardiovascular and/or interventional medical devices, including non-invasive diagnostic devices and instruments, invasive and implantable devices, and surgical systems.
• Excellent written and verbal communication skills.
• Excellent interpersonal skills and ability to work effectively both independently and within a team of 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 guidances.

Responsibilities

• Provide expert consulting services to assist CDRH with its regulatory responsibilities.
• Provide consultation supporting 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.
• Conduct research and data analysis.
• Write detailed documents and reports.
• Perform 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