Medical Officer - Plastic Surgeon

Responsibilities

In general, these consultants 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; and execute other administrative office tasks related to CDRH's projects.

Requirements

• A Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States.
• 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 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.
• A thorough understanding of current clinical practices in plastic surgery, including diagnosis and treatment, and current/emerging trends in practice.
• Expertise 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).
• Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 878 – General and Plastic Surgery Devices), and guidances is preferred.
• Excellent written and verbal communication skills.
• Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.

Qualifications

• This position is 100% telework.
• Must be a US Citizen or a Full Green Card holder.