[Hiring] Orthopedic 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, Inc. is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval of medical devices.

• Provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions).
• 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.

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 orthopedic 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 ten (10) years of relevant clinical experience.
• Certification from a U.S. relevant specialty board organization, e.g., the American Board of Orthopedic Surgery (ABOS).
• Thorough understanding of current clinical practices in orthopedic surgery, including diagnosis and treatment, and current/emerging trends in practice.
• Expert in function and utilization of medical devices commonly used as part of orthopedic surgery.
• Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 878 – General and Plastic Surgery 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.
• Must be a US Citizen or a Full Green Card holder.

Requirements

• This position is 100% telework.

Benefits

• 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.