U.S. Food and Drug Administration (FDA)
Center for Devices and Radiological Health (CDRH)
Office of Product Evaluation and Quality (OPEQ)
Office of Surgical and Infection Control Devices
The Office of Surgical and Infection Control Devices (also known as the Office of Health Technology 4 or OHT4) within CDRH’s OPEQ is searching for an outstanding executive physician interested in working in a challenging and dynamic environment overseeing a staff of ~50 scientists, engineers, DVMs, and MDs by serving as the Division Director for the Division of General Surgery Devices.
What We Do: The Division of General Surgery Devices within OPEQ’s OHT4 is responsible for FDA’s regulatory oversight of cutting-edge general surgery devices. Products areas include electrosurgical devices, minimally invasive surgery devices, laser and light-based devices, robotic assisted surgery devices, microwave, ultrasound, and cryosurgery devices, and point of care diagnostics, among others. We:
• Serve as the primary source for scientific and medical expertise with regard to safety and effectiveness of medical devices throughout the total product lifecycle.
• Provide initial support for questions related to regulatory programs in response to requests from medical device and health technology industries, trade associations, other Federal agencies, other countries, State agencies, and the general public.
• Advise, coordinate, and provide consultation to the OPEQ Director and other Agency officials on Office programs and policies concerning premarket review, compliance and quality, and postmarket surveillance activities.
• Coordinate, carry out, and make premarket review, postmarket compliance, quality and surveillance determinations.
• Participate in development and interpretation of post market regulations and policies.
• Coordinate actions on classification.
• Review and evaluate design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.
• Participate in the development of national and international consensus standards, and voluntary guidelines through interaction with national and international standards committees.
• Extensive supervisory and/or leadership experience in diverse organizations
• Medical training and license to practice medicine in the US
• Experience working in dynamic team environments
• Highly developed analytical, time management, organizational and written and oral communication skills
• Experience with robotic assisted surgical devices
• Knowledge of FDA regulations
Location: Our offices are located in Silver Spring, Maryland.
Salary: Salary is commensurate with education and experience (typically in the range of $190,000-$210,000).
Benefits: Outstanding leave package, Health Insurance, Life Insurance, Retirement, Maxiflex Schedule, Telecommuting, Health Units, Fitness Centers and participation in Federal Credit Unions. There are opportunities for professional development, which may include further training, attendance at scientific meetings and conferences, and clinical activities.