FDA CDRH Office of Cardiovascular Devices Position Description - Cardiologist (Heart Failure SME)The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.
Tunnell Government Services is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval of medical devices.In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PMA, HDE and De Novo marketing applications, Pre-submissions, Investigational Device Exemptions, Recalls); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office tasks related to CDRH's projects.
Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and cardiology, as relevant to medical devices.
Requirements and Qualifications
- The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States.
- In addition, the candidate must possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
- At least fifteen (15) years of relevant clinical experience
- Certification from a U.S. relevant specialty board organization (e.g., the American Board of Internal Medicine, American College of Cardiology, etc.)
- Specialized qualifications related to the subspecialty of Advanced Heart Failure and Transplant Cardiology (e.g., completed an Advanced Heart Failure & Transplant Cardiology fellowship, clinical practice in Advanced Heart Failure/Heart Transplantation)
- Thorough understanding of current clinical practices in cardiovascular medicine, including diagnosis and treatment, and current/emerging trends in practice.
- Expert in function and utilization of cardiovascular and/or interventional medical devices (e.g., angioplasty devices, external/internal defibrillators, ablation catheters, pacemakers, prosthetic valves, stents, etc.), to include specific knowledge of non-invasive devices and instruments used for diagnosis; invasive devices, such as implantable devices; and surgical systems.
- Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 870 -- Cardiovascular Devices), and guidances is preferred.
- Ability to communicate well with others using excellent written and verbal communication skills.
- Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel (i.e., engineers, statisticians, biologists, etc.).
This position is 100% telework.
Must be a US Citizen or full Green card holder.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
