Vascular Surgeon

Tunnell Government Services; 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., 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.

FDA CDRH

Office of Cardiovascular Devices

Vascular Surgeon Position Description

The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

Tunnell Government Services is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PMA, HDE and De Novo marketing applications, Pre-submissions, Investigational Device Exemptions, Recalls); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office tasks related to CDRH’s projects.

Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in vascular surgery, as relevant to medical devices.

Requirements and Qualifications

• The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States.
• In addition, the candidate must possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
• At least fifteen (15) years of relevant clinical experience
• Certification from a U.S. relevant specialty board organization, e.g., the American Board of Surgery (ABS) certification in Vascular Surgery, etc.
• Thorough understanding of current clinical practices in cardiovascular medicine, including diagnosis and treatment, and current/emerging trends in practice.
• Specialized training and experience necessary for the subspecialty of vascular surgery, e.g., completion of an integrated vascular surgery residency, or completion of a traditional surgical residency and a vascular surgery fellowship.)
• Expert in function and utilization of cardiovascular and/or interventional medical devices (e.g., angioplasty balloons, vascular stents, carotid stent systems, EVAR grafts, TEVAR devices, mechanical thrombectomy systems, AV grafts, dialysis catheters, venous stents, endovenous ablation systems, introducer sheaths, intravascular ultrasound, etc.) to include specific knowledge of non-invasive devices and instruments used for diagnosis; invasive devices, such as implantable devices; and surgical systems.
• Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 870 – Cardiovascular Devices), and guidances is preferred.
• Ability to communicate well with others using excellent written and verbal communication skills.
• Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel (i.e., engineers, statisticians, biologists, etc.).

This position is 100% telework.

Must be a US Citizen or Full 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.