[Hiring] Vascular Surgeon @Tunnell Government Services

Role 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)
• Participation in meetings and teleconferences
• Coordination of meetings with internal and external stakeholders
• Development of written reviews and correspondence
• Research and data analysis
• Writing detailed documents and reports
• Execution of 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 vascular surgery, as relevant to medical devices.

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 Surgery (ABS) certification in Vascular Surgery
• Thorough understanding of current clinical practices in cardiovascular medicine, including diagnosis and treatment, and current/emerging trends in practice
• Specialized training and experience necessary for the subspecialty of vascular surgery
• 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

• Attraction of qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran