Cardiologist (Heart Failure SME)

Tunnell Government Services, Inc.; Oregon; Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

100% telework

Job summary

Tunnell Government Services, Inc. seeks a Cardiologist (Heart Failure SME) to support FDA CDRH regulatory reviews related to cardiovascular devices.

The role requires deep clinical expertise and the ability to translate medical insights into regulatory documents. Candidates must be US physicians with active licensure, board certification in cardiology, and extensive experience in advanced heart failure and transplant cardiology.

Qualifications

• MD from an accredited US medical school.
• Active, unrestricted medical license to practice in the United States.
• Minimum fifteen (15) years of relevant clinical experience.
• Board certification in cardiology (e.g., ABIM, ACC).
• Specialized qualifications in Advanced Heart Failure and Transplant Cardiology.
• Thorough understanding of cardiovascular medicine and devices used in care.

Responsibilities

• Provide expert consulting to assist FDA CDRH with regulatory responsibilities for cardiovascular devices.
• Coordinate meetings with internal and external stakeholders; develop written reviews and reports.
• Perform data analysis and write detailed documents and reports related to regulatory reviews.

Skills

Clinical communication

Team collaboration

Regulatory knowledge

Medical device familiarity

Project coordination

Education

Doctor of Medicine (M.D.)

Medical license (US)

Fifteen years of clinical experience

Board certification in cardiology

Advanced Heart Failure and Transplant Cardiology fellowship

Job description

About Tunnell Government Services

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. We are an employee‑owned company that develops and implements innovative, integrated, and differentiated solutions.

FDA CDRH Office of Cardiovascular Devices

The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote public health. CDRH ensures patients and providers have timely and continued access to safe, effective, and high‑quality medical devices and safe radiation‑emitting products.

Position Description – Cardiologist (Heart Failure SME)

Tunnell Government Services provides professional and scientific services to the CDRH with expert consultants in the regulation and approval of medical devices. Consultants support medical device reviews (EUA, 510(k), PMA, HDE, 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. The 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.

Equal Opportunity Employer

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. 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.