[Hiring] Cardiologist @Tunnell Government Services

Role Description

Tunnell Government Services is providing professional and scientific services to the FDA Center for Devices and Radiological Health (CDRH) with expert consultants with scientific expertise in the regulation and approval of medical devices. The candidate will provide expert consulting services to assist the CDRH with their regulatory responsibilities.

• 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 and conduct data analysis
• Write detailed documents and reports
• Execute other administrative office tasks related to CDRH’s projects

Qualifications

• Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States
• 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
• 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
• 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
• This position is 100% telework
• Must be a US Citizen or full Green card holder

Requirements

• Compliance with all client requirements, including any safety and health protocols

Benefits

• Commitment to hiring and retaining the most qualified talent
• Consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran