Electrical Engineer & Regulatory Reviewer (Radiology)

Tunnell Government Services, Inc.; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Tunnell Government Services, Inc. is seeking an Electrical Engineer / Regulatory Scientific Reviewer (Radiological Health) to provide scientific, engineering, and regulatory review support for radiation therapy and radiological health applications within FDA's Center for Devices and Radiological Health (CDRH).

The reviewer evaluates the safety, effectiveness, performance, and regulatory characteristics of complex radiation-emitting medical devices throughout the product lifecycle and supports

Qualifications

• Bachelor's degree or higher in Electrical Engineering from ABET-accredited institution.
• At least 10 years of professional experience.
• Experience with radiation therapy systems or related healthcare technologies.
• Knowledge of medical device design, testing, safety standards, and healthcare technology applications.

Responsibilities

• Review premarket and postmarket data for radiation therapy medical devices.
• Evaluate electrical, mechanical, software, and systems aspects for safety and regulatory compliance.
• Analyze device performance, failure modes, recalls, and safety signals.
• Conduct technical assessments of design controls, risk management, and cybersecurity.
• Prepare scientific reviews, technical memoranda, and regulatory recommendations.
• Collaborate with multidisciplinary teams and communicate findings.

Skills

Analytical skills

Technical writing

Communication skills

Education

Electrical Engineering degree (ABET-accredited)

Job description

Tunnell Government Services, Inc. is seeking an Electrical Engineer / Regulatory Scientific Reviewer (Radiological Health) to provide scientific, engineering, and regulatory review support for radiation therapy and radiological health applications within FDA's Center for Devices and Radiological Health (CDRH).

The reviewer evaluates the safety, effectiveness, performance, and regulatory characteristics of complex radiation-emitting medical devices throughout the product lifecycle and supports