Cardiologist (Heart Failure SME)

Tunnell Government Services, Inc.; Bethesda (MD); Remote; USD 260,000 - 320,000; Full time

Job summary

Tunnell Government Services, Inc. seeks a Cardiologist (Heart Failure SME) to support the FDA CDRH Office of Cardiovascular Devices in a 100% telework role.

The candidate will bring advanced clinical expertise in cardiovascular medicine, including heart failure and transplant care, and will contribute to regulatory reviews, guidance, and strategic advice. Required are an active MD license in the United States, 15+ years of clinical experience, and subspecialty certification.

Qualifications

• MD from an accredited US medical school and an active medical license or registration in a US jurisdiction.
• Fellowship in Advanced Heart Failure and Transplant Cardiology or equivalent subspecialty training.
• 15+ years of relevant clinical experience in cardiovascular medicine.
• Familiarity with FDA medical device regulations (e.g., 21 CFR Part 870).
• Strong verbal and written communication and teamwork skills.

Responsibilities

• Provide expert consulting to assist FDA CDRH with regulatory responsibilities for cardiovascular devices.
• Prepare reviews, data analyses, and written reports; participate in meetings and teleconferences.
• Coordinate with engineers, statisticians, biologists, and other stakeholders on project deliverables.
• Maintain up-to-date knowledge of cardiovascular device practice and regulatory guidance.

Skills

Cardiology expertise

Communication skills

Team collaboration

Education

MD from accredited US medical school

Board certification in Cardiology/Internal Medicine

Job description

Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.
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.
Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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.