Medical Physicist

Tunnell Government Services • Bethesda, MD

13h • Onsite

About The Position

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 click on the links below to find the job that is right for you and contact us.

The Division of Radiological Imaging and Radiation Therapy Devices (DHT8C) within FDA CDRH Office of Radiological Health has the responsibility for reviewing pre-market submissions and managing post-market / compliance activities for Radiological products and radiation-emitting consumer products. To conduct its business, DRH is in need for specialized technical and expert regulatory review support services from personnel who are not full time FDA Staff. Specialized/expert support services are needed to review regulatory submissions and post-market / compliance activities that involve radiation oncology devices and radiologic imaging devices. The types of pre-market regulatory submissions that DRH needs assistance with includes 510(k), PMA, Pre-IDE, IDE and 513(g) submissions. The types of post-market / compliance activities that DRH needs assistance with includes Recalls, Establishment Inspection Reports (EIR), Electronic Product Radiation Control (EPRC), Medical Device Reports (MDR) and Trade Complaints. This is a part-time role, approximately 23 hours/month. This role is contingent upon contract being awarded.

Requirements

• MS or PhD in Medical Physics or closely related field.
• Recent experience as a clinical therapy physicist.
• 15-20 years of total experience in the field of Medical Physics.
• Experience across all aspects of radiation oncology physics, including quality assurance, external beam, and brachytherapy clinical support.
• Must be a US Citizen or a Green Card Holder.

Nice To Haves

• Board certification by the American Board of Radiology (ABR), Certification in Medical Physics, is preferred.
• 3 of the last 5 years of recent experience as a clinical therapy physicist is preferred.
• FLASH experience is preferred.

Responsibilities

• Reviewing pre-market submissions for Radiological products and radiation-emitting consumer products.
• Managing post-market / compliance activities for Radiological products and radiation-emitting consumer products.
• Reviewing regulatory submissions and post-market / compliance activities involving radiation oncology devices and radiologic imaging devices.
• Assisting with 510(k), PMA, Pre-IDE, IDE and 513(g) submissions.
• Assisting with Recalls, Establishment Inspection Reports (EIR), Electronic Product Radiation Control (EPRC), Medical Device Reports (MDR) and Trade Complaints.

What This Job Offers

• Job Type: Part-time
• Career Level: Senior