Remote Vascular Surgeon & Regulatory Consulting Expert

Tunnell Government Services, Inc.; United States; Remote; USD 260,000 - 400,000; Full time

Job summary

Tunnell Government Services, Inc. seeks an experienced vascular surgeon to provide expert regulatory consulting for FDA CDRH, Office of Cardiovascular Devices, in a 100% telework role. You will support medical device reviews (EUA, 510(k), PMA, De Novo), meetings, and written analyses.

Candidates must have an MD from a US medical school, an active US medical license, 15+ years of clinical experience, ABS vascular surgery certification, and familiarity with FDA processes. U.S.

Qualifications

• MD from an accredited U.S. medical school.
• Current, active, full medical license to practice in the United States.
• At least 15 years of relevant clinical experience.
• Board certification in vascular surgery (e.g., ABS).
• Thorough understanding of cardiovascular medicine and devices.
• Familiarity with FDA medical device regulatory processes (preferred).

Responsibilities

• Provide expert consulting to assist CDRH with regulatory responsibilities.
• Develop written reviews and correspondence; participate in meetings and teleconferences.
• Coordinate with internal and external stakeholders; conduct data analysis and write reports.
• Support regulatory submissions and related documentation (EUA, 510(k), PMA, De Novo).

Skills

Communication

Teamwork

Regulatory knowledge

Leadership

Vascular surgery

Education

MD (US)

Medical license (US)

Job description

Tunnell Government Services, Inc. seeks an experienced vascular surgeon to provide expert regulatory consulting for FDA CDRH, Office of Cardiovascular Devices, in a 100% telework role. You will support medical device reviews (EUA, 510(k), PMA, De Novo), meetings, and written analyses.

Candidates must have an MD from a US medical school, an active US medical license, 15+ years of clinical experience, ABS vascular surgery certification, and familiarity with FDA processes. U.S.