Medical Physicist Tunnell Government Services, Inc., is comprised of the industry's leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please contact us. The FDA Center for Devices and Radiological Health (CDRH), Office of Radiological Health, Division of Radiological Imaging and Radiation Therapy Devices (DHT8C), is seeking a full-time or part-time, fully remote contractor to provide specialized technical and regulatory support for the review of radiation oncology, radiological imaging, nuclear medicine, and radiation-emitting products.
Key Responsibilities:
Conduct technical reviews of medical device regulatory submissions, including 510(k), PMA, Pre-IDE, IDE, and 513(g) submissions.
Provide expert support for postmarket and compliance activities, including Medical Device Reports (MDRs), recalls, Establishment Inspection Reports (EIRs), Electronic Product Radiation Control (EPRC) issues, and trade complaints.
Evaluate radiation oncology, nuclear medicine, and radiologic imaging technologies for safety, effectiveness, performance, and clinical application.
Review dosimetry methodologies, software systems, and dose calculation algorithms associated with nuclear medicine and radiopharmaceutical therapy devices.
Provide subject matter expertise in radiation oncology physics, including quality assurance, external beam radiation therapy, and brachytherapy.
Interpret and apply relevant FDA regulations, guidance documents, consensus standards, and risk management principles to support regulatory decision-making.
Minimum Qualifications:
Master's degree or PhD in Medical Physics or a closely related scientific discipline.5-10 years of professional experience in medical physics.
Demonstrated expertise in radiation oncology physics, including quality assurance, external beam therapy, and brachytherapy.
Extensive experience with dosimetry, nuclear medicine devices, and radiopharmaceutical therapy dose calculation software.
Working knowledge of applicable FDA medical device regulations, guidance documents, relevant sections of 21 CFR, and recognized national and international consensus standards applicable to radiation oncology, nuclear medicine, and radiologic imaging devices.
U.S. Citizen or Lawful Permanent Resident (Green Card Holder).
Preferred Qualifications:
American Board of Radiology (ABR) certification in Medical Physics.
Experience supporting FDA-regulated medical devices, including premarket review, compliance, quality systems, and postmarket activities.
Familiarity with FDA-recognized standards and guidance documents related to radiation-emitting products, medical imaging systems, radiation therapy devices, software, and cybersecurity.
Position Type:
Full-Time Contractor Work Location: Fully Remote (U.S.-Based) Organization Supported: FDA CDRH, Office of Radiological Health, Division of Radiological Imaging and Radiation Therapy Devices (DHT8C) Must be a US Citizen or a Green Card Holder. 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. To attract qualified applicants, Tunnell posts to a wide variety of job sites. 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. Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
