Veterinary Medical SME

Tunnell Government Services • Bethesda, MD

16h • Remote

About The Position

The successful candidate will serve as a clinical and technical authority to a variety of internal and external stakeholders regarding an array of medical and radiological health products. They will provide scientific, technical, product development, and product validation advice as part of research protocol review, assessment of technical data included in regulatory submissions, as relevant to regulatory review of medical devices. Such submissions include Premarket Notification (510(k)), Premarket Approval Application (PMA), etc.

Requirements

• Doctor of Veterinary Medicine (DVM) degree or equivalent
• Unrestricted license to practice veterinary medicine in a state or territory of the United States
• 7 years of experience (clinical, academic, and/or industry experience)
• General knowledge and experience with a variety of medical device development technical disciplines
• Exceptionally strong written and verbal communication skills
• 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
• Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.)
• Must be a US Citizen or a Full Green Card holder.

Nice To Haves

• Additional advanced degrees (MS, PhD) or Board certifications in a related/applicable field are strongly preferred.

Responsibilities

• Provide expert consultant service in the area of Veterinary Medicine and use of animal models as related to Human Medical Device Regulatory Review, consistent with (but not limited to) applicable consensus standards.
• Provide expert consultation services to OHT review teams in support of medical device reviews, specifically applying expertise in the planning, conduct and review of animal studies used to validate the feasibility, safety and/or efficacy of medical devices.
• Participate in meetings to discuss these device submissions with both internal and external sponsors.
• Write reviews and assist with development of other documents as needed.
• Assist OHT staff as needed with projects in OPEQ’s OHTs including but not limited to: conducting interviews, attending meetings, data analysis, communications with internal and external stakeholders, and writing drafts of internal and external communication.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree