Interventional Cardiologist

Tunnell Government Services, Inc.; Oregon; Hybrid; USD 300,000 - 600,000; Full time

Job summary

Tunnell Government Services, Inc. seeks an expert Interventional Cardiologist to provide consulting support to the FDA CDRH on cardiovascular device regulation.

The role emphasizes clinical medicine, device expertise, and regulatory guidance. The position is 100% telework in the United States; candidates must hold MD, US medical license, ABIM Interventional Cardiology certification, and 15+ years of clinical experience.

Qualifications

• MD from an accredited US medical school.
• Active medical license in the United States.
• 15+ years of relevant clinical experience.
• Board certification in relevant cardiology specialty (e.g., ABIM Interventional Cardiology).
• Specialized training in interventional cardiology and related procedures.
• Familiarity with FDA medical device regulatory processes.

Responsibilities

• Provide expert consulting to assist FDA CDRH regulatory responsibilities.
• Develop written reviews and correspondence on device regulation.
• Coordinate meetings with internal and external stakeholders.
• Conduct research, data analysis, and prepare detailed reports.

Skills

Cardiology expertise

Regulatory knowledge

Communication skills

Team collaboration

Independent work capability

Education

MD (US residency)

Board certification in cardiology

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.

FDA CDRH Office of Cardiovascular Devices Interventional Cardiologist Position Description

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, ABIM Interventional Cardiology, etc.
• Completed specialized training and experienced in areas requisite to be a subject matter expert in interventional cardiology (e.g., completed Interventional Cardiology fellowship; clinical practice and advanced training in minimally invasive, catheter-based procedures, such as cardiac catheterization, percutaneous coronary intervention (PCI), transcatheter aortic valve repair (TAVR), etc.)
• 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.