Medical Officer - Plastic Surgeon

Tunnell Government Services • Bethesda, MD

4h • Remote

About The Position

Tunnell Government Services, Inc. is seeking a Medical Officer with expertise in Plastic Surgery to provide expert consulting services to the FDA Center for Devices and Radiological Health (CDRH). The mission of CDRH is to protect and promote public health by ensuring timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. This role involves supporting CDRH's regulatory responsibilities, including medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions), participating in meetings and teleconferences, coordinating with internal and external stakeholders, developing written reviews and correspondence, performing research, conducting data analysis, writing detailed documents and reports, and executing other administrative office tasks related to CDRH’s projects. The candidate must possess specific expertise and training in clinical medicine and plastic surgery, as relevant to medical devices.

Requirements

• 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 Plastic Surgery (ABPS), etc.
• Thorough understanding of current clinical practices in plastic surgery, including diagnosis and treatment, and current/emerging trends in practice
• Expert in function and utilization of medical devices commonly used as part of plastic surgery (e.g., aesthetic and body contouring devices [liposuction systems, energy-based skin tighteners, lasers], precision cutting and dissection tools (e.g., electrosurgical units, dermatomes, skin graft meshers), microsurgical equipment (operating microscopes, micro-instruments, doppler ultrasound), breast and implant-related tools (tissue expanders, keller funnel), craniofacial and bone tools (piezoelectric bone scalpels, internal fixation systems) to include specific knowledge of non-invasive devices and instruments used for diagnosis; invasive devices, such as implantable devices; and surgical systems
• 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

Nice To Haves

• Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 878 – General and Plastic Surgery Devices), and guidances is preferred

Responsibilities

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 11-50 employees